Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Skylar Jeremias

The rising cost of oncology care continues to strain health care budgets, prompting payers and providers to seek sustainable strategies that maintain high-quality clinical outcomes without compromising financial stability. 

For managed care organizations, the integration of biosimilars into formularies represented a critical avenue for mitigating these expenses, particularly regarding supportive care therapies for metastatic bone disease.

Biosimilar denosumab offers significant cost savings and improved access to treatment, alleviating financial burdens in oncology care while enhancing patient outcomes. | Image credit: เด็กชาย นุ่มนิ่ม - stock.adobe.com

 evaluated the potential financial implications of adopting biosimilar denosumab within a United States health plan. The research aimed to quantify the cost savings associated with switching from reference denosumab to a biosimilar and to estimate the clinical benefits of reinvesting those savings to expand access to treatment.

Skeletal-related events (SREs), such as pathologic fractures and spinal cord compression, are common complications for patients with metastatic cancer, significantly driving up medical costs and morbidity. While denosumab is a standard of care for preventing these events, its cost has historically been higher than alternative bisphosphonates like zoledronic acid.

The researchers developed two economic models from a US payer perspective to assess the impact of biosimilar denosumab over a 5-year period. The hypothetical model assumed a health plan covering 1 million lives, with a target population including patients with metastatic breast cancer, prostate cancer, multiple myeloma, and solid tumors.

The first model calculated the direct cost savings from converting patients from the reference denosumab products (Prolia and Xgeva) to a biosimilar. The second model explored a reinvestment scenario where the realized savings were used to transition patients currently treated with zoledronic acid to biosimilar denosumab, thereby expanding access to biological therapy.

The study projected substantial savings for payers who adopted biosimilar denosumab. In the base case scenario, which assumed a medium market conversion rate reaching 57.30% for oncology indications and 81.79% for osteoporosis indications by year 5, the total cost savings amounted to $38,677,606. This equated to a savings of $0.59 per member per month (PMPM) by the fifth year.

The investigators also modeled high and low conversion scenarios to account for market variability. A high conversion rate yielded a 5-year net savings of approximately $55.9 million ($0.85 PMPM), while a low conversion rate still resulted in savings of roughly $23 million ($0.35 PMPM).

Pricing assumptions played a significant role in the magnitude of these savings. The authors noted that even with a conservative 5% price reduction relative to the reference product, the plan saved over $5.7 million. On the other end of the spectrum, an 85% price reduction resulted in projected savings of nearly $97 million over the 5-year horizon.

Beyond direct financial savings, the study highlighted the potential for improved clinical outcomes through resource reallocation. When savings were reinvested to treat patients previously receiving zoledronic acid, the model demonstrated that the health plan could treat approximately 100 additional patients with biosimilar denosumab for every 10% increase in reinvestment.

In the base case, reinvesting savings allowed for the treatment of an additional 998 patients. Consequently, the model predicted that this expanded access prevented 28.2 additional SREs and fractures over the 5-year period. This reduction in adverse events further compounded the value proposition by avoiding the high costs associated with inpatient hospitalizations and surgeries for bone complications.

The authors acknowledged several limitations to their modeling approach. The cost inputs relied on historical pricing trends for biosimilars relative to reference products, which may not have perfectly reflected current average sales prices (ASP) or payment limits at the time of implementation. Specifically, the model assumed a pricing structure that included a discount off the reference ASP plus an inflationary adjustment, which might have varied in real-world contracting.

Additionally, the 5-year time horizon may not have captured long-term outcomes for patients with chronic metastatic disease. The model also treated indications as mutually exclusive, potentially leading to double-counting in rare instances where a patient might have qualified for multiple indications. Finally, the reliance on published literature for discontinuation rates and SRE costs meant that the results might not have been generalizable to every specific health system or patient population.

The findings suggested that biosimilar denosumab offered a viable pathway for oncology practices and payers to reduce the total cost of care. For practices participating in value-based care arrangements, such as the Enhancing Oncology Model, these savings could be instrumental in managing financial risk. 

By lowering the barrier to entry for biological therapy, the introduction of biosimilar denosumab appeared to support a more sustainable economic model while maintaining, or potentially improving, patient access to essential supportive care.

Flanigan J, Chaplin S, van Stiphout J, et al. A budget impact model for biosimilar denosumab for skeletal-related events and fractures in the United States oncology population. 

. 2025;28(1):2027-2038. doi:10.1080/13696998.2025.2584885

Articles

Biosimilar denosumab offers significant cost savings and improved access to treatment, alleviating financial burdens in oncology care while enhancing patient outcomes.

Economic Analysis Supports Formulary Shift to Biosimilar Denosumab

As health systems continue expanding the use of high-concentration adalimumab biosimilars, new real-world data from 2 Australian hospitals offered a closer look at how people living with Crohn disease experienced self-injection with CT-P17 (Yuflyma), a citrate-free biosimilar administered via autoinjector.

 provided early insights into patient satisfaction, ease of use, and tolerability—factors that play a substantial role in adherence for long-term biologic therapy.

Patients with Crohn disease report high satisfaction and minimal discomfort using the citrate-free biosimilar CT-P17, enhancing adherence to treatment. | Image credit: DachAI - stock.adobe.com

Researchers conducted the study to address an evidence gap around patient-reported experiences with CT-P17 specifically in individuals with Crohn disease. Although prior trials and observational reports have established CT-P17’s pharmacokinetic and safety equivalence to reference adalimumab, limited research has focused on how people perceive the device design, injection comfort, and overall usability in the inflammatory bowel disease (IBD) population. Understanding these patient-centered considerations is essential for payers and clinicians working to expand biosimilar adoption.

The study included 15 adults with Crohn disease (median age, 39.9 years) treated at Macquarie University Hospital and Concord Repatriation General Hospital. All participants had previous experience with at least 1 biologic therapy—most commonly reference adalimumab—and all had used an autoinjector prior to CT-P17. Participants either transitioned from an adalimumab product to CT-P17 or had been receiving CT-P17 for at least 4 weeks before completing the assessment.

Researchers collected baseline demographics and disease activity using the Harvey Bradshaw Index (HBI). They used the Self-Injection Assessment Questionnaire (SIAQ), a validated tool designed to capture patient experiences with self-administration, including emotional response, confidence, physical discomfort, and satisfaction. SIAQ domain scores range from 0 (worst) to 10 (best), with higher values indicating more positive experiences.

Across domains, participants reported favorable perceptions of CT-P17. Mean (SD) post-transition scores indicated high comfort with injections (8.3 [1.7]) and strong self-confidence during administration (8.4 [1.5]). Many individuals reported that self-injection did not negatively affect their self-image, reflected in a mean score of 9.0 (2.6).

Notably, participants reported minimal pain and skin reactions, producing one of the highest domain scores (9.2 [0.9]). Researchers highlighted this finding in the context of CT-P17’s citrate-free, high-concentration formulation, which was designed to reduce injection discomfort compared with citrate-buffered products. Ease of use of the autoinjector also received strong ratings, with a mean score of 8.8 (1.9). Overall satisfaction mirrored these results (8.8 [1.4]), suggesting general acceptance and comfort with self-administration of the biosimilar.

Participants also reported low disease activity based on HBI scores, which averaged 0.7 (range, 0-3). Because the study did not evaluate clinical efficacy, the HBI measure primarily offered context on disease stability rather than treatment response.

The authors noted that these results aligned with findings from prior research in other immune-mediated inflammatory diseases, including rheumatoid arthritis, where CT-P17 has demonstrated comparably positive SIAQ scores. Device features such as ergonomic design, cap removal forces optimized for ease of handling, and clear injection feedback may contribute to patient comfort and confidence. These design elements may be especially meaningful for individuals who experience dexterity limitations or needle anxiety—factors that have been shown in other studies to influence whether patients persist with biologic therapy.

Although the results were promising, the study had several limitations. The sample size was small and limited to 2 specialized hospitals, restricting generalizability. The cross-sectional design captured only a snapshot of early experiences, preventing evaluation of long-term satisfaction, persistence, or adverse events beyond injection-site reactions. The researchers also noted that the SIAQ relies on self-reported data, which may introduce recall bias or underreporting of negative experiences.

Still, the findings contributed to a growing body of evidence suggesting that biosimilar autoinjectors designed with patient usability in mind may support smoother transitions from reference products and help maintain adherence. For managed care organizations, these insights may inform formulary decisions and patient support strategies, particularly as high-concentration adalimumab biosimilars continue to expand their presence in global markets.

The authors concluded that individuals with Crohn disease who transitioned to or continued therapy with CT-P17 generally reported high satisfaction and minimal discomfort, reinforcing the biosimilar’s potential role in promoting patient autonomy and reducing system-level costs. Larger and longer-duration studies are needed to confirm these findings and further explore patient preferences across device types and biosimilar formulations.

Zheng D-Y, Zhou L-Y, Huang Y-H, Jiang M, Dai C. Biosimilar switching in IBD: safety, efficacy, and immunogenicity in 10,812 patients - a systematic review and meta-analysis. 

. Published online November 17, 2025. doi:10.17235/reed.2025.11653/2025

Patients with Crohn disease report high satisfaction and minimal discomfort using the citrate-free biosimilar CT-P17, enhancing adherence to treatment.

Patient Experiences With CT-P17 Suggest Strong Satisfaction and Ease of Injection

People living with hidradenitis suppurativa (HS) often rely on long-term biologic therapy to manage painful and recurring inflammatory symptoms, but access to treatment can be shaped by cost, formulary design, and pharmacy-level decisions.

 As biosimilars increasingly become the default option in many health systems, new real-world data provide important insight into how these products may perform in a chronic condition where treatment stability is a core goal.

New research reveals that switching from originator to biosimilar adalimumab for hidradenitis suppurativa may lead to reduced treatment effectiveness and stability. | Image credit: Orawan - stock.adobe.com

, evaluated clinical outcomes among adults with HS who initiated either originator or biosimilar adalimumab between April 2021 and December 2024. It also examined outcomes for individuals who initially responded to originator adalimumab but were later transitioned to a biosimilar due to nonmedical formulary changes—an increasingly common scenario as payers shift toward lower-cost products.

HS is a chronic, painful inflammatory skin disease characterized by nodules, abscesses, and tunnels that often require durable immunomodulation. While biosimilars are designed to replicate the safety and efficacy of the reference biologic, small manufacturing variations can influence immunogenicity or drug persistence, prompting ongoing debate about whether the 2 product types perform equivalently in certain conditions. Because adalimumab remains 1 of the few available biologic options for HS, questions about switching and long-term control are particularly relevant for both clinicians and managed care organizations.

The analysis included 313 treatment-naïve individuals with dermatologist-confirmed HS. Those who initiated the originator product (n = 186) and those who started a biosimilar (n = 127) demonstrated similar baseline demographics, including median age (31 vs 30 years), sex distribution, body mass index (BMI), smoking status, and Hurley stage. All individuals followed the same dosing regimen recommended by major regulatory agencies.

A second matched cohort assessed the effects of nonmedical switching. Seventy-one individuals who achieved clinical response (HiSCR-50) on originator adalimumab at week 16 and were subsequently switched to a biosimilar were compared with 71 matched individuals who remained on the originator product. Matching ensured comparability across age, sex, BMI, smoking status, and Hurley stage.

Clinical outcomes were measured using established HS tools: HiSCR-50, HiSCR-75, and the International Hidradenitis Suppurativa Severity Scoring System (IHS4-55). Time-to-event analysis evaluated loss of response, defined as loss of HiSCR-50.

Differences in Response and Durability Emerge Over Time

Early outcomes at week 16 showed similar proportions achieving HiSCR-50 across treatment-naïve groups (

 = .27), but the originator group demonstrated a significantly higher rate of HiSCR-75 (33% vs 30%; 

 = .008). By week 52, differences across all measures widened, with originator-treated individuals more likely to achieve:

Durability of response followed a similar pattern. Median time to loss of HiSCR-50 was 100 weeks for originator-treated individuals compared with 52 weeks for biosimilar-treated individuals, with a hazard ratio of 2.73 for loss of response among biosimilar users (

 < .0001). In adjusted regression analysis, biosimilar initiation was associated with a 77% increased odds of losing clinical response (odds ratio = 1.767; 

For those who switched after early response, the median time to loss of HiSCR-50 was 50 weeks compared with 87 weeks among individuals who remained on the originator (hazard ratio, 2.42; 

 = .0003). Switching was associated with nearly a threefold increase in the odds of losing clinical response (odds ratio = 2.807; 

 = .0024) after adjustment for body mass index and Hurley stage.

Investigators noted that the retrospective design and variability in biosimilar formulations across sites were key limitations. Despite this, the sample size exceeded that of prior HS-focused biosimilar assessments, and matching in the switching cohort strengthened the interpretability of those comparisons.

The findings aligned with earlier reports suggesting that some individuals with HS may experience loss of response or reduced tolerability following nonmedical switching. Previous reports have also documented injection-site reactions and reduced effectiveness after transitions from the originator product, though evidence has varied depending on condition and population.

Beyond pharmacologic and immunogenic factors, the nocebo effect may play a meaningful role in real-world outcomes when individuals with HS are switched from originator biologics to biosimilars. The nocebo effect occurs when negative expectations or beliefs about a treatment contribute to perceived or actual worsening of symptoms, reduced adherence, or discontinuation, even when the therapy is pharmacologically equivalent. In chronic conditions like HS, where treatment stability is essential for maintaining disease control and preventing painful flares, the psychological impact of nonmedical switching may amplify the risk of symptom recurrence or perceived loss of efficacy.

Evidence from the study highlights that individuals who were stable on originator adalimumab but transitioned to a biosimilar experienced a median time to loss of clinical response that was nearly halved compared with those who remained on the originator. While manufacturing differences and immunogenicity could partially explain these findings, prior research in other inflammatory diseases suggests that patient expectations and concerns about efficacy and tolerability can contribute significantly to reduced response following nonmedical switching. Injection-site reactions, fatigue, or other subjective experiences may be interpreted as treatment failure, leading to decreased adherence or premature discontinuation.

Acknowledging the potential role of the nocebo effect has important implications for clinical practice and managed care strategies. Clinicians and pharmacy teams can mitigate its impact through proactive education, transparent communication about biosimilar equivalence, and shared decision-making that addresses patient concerns. Ensuring that patients understand the rationale for switching, the regulatory rigor behind biosimilar approval, and strategies for monitoring disease control may help preserve confidence in therapy and maintain long-term outcomes.

In the context of expanding biosimilar adoption for HS, integrating strategies to minimize the nocebo effect alongside careful monitoring of clinical response will be key to optimizing both patient experience and therapeutic durability.

Implications for Clinical and Managed Care Decision-Making

As biosimilar use expands, formulary changes often occur independently of clinical concerns, placing individuals with stable disease at potential risk of unintended therapeutic disruption. For a chronic inflammatory condition marked by recurrent flares and limited biologic alternatives, treatment consistency remains a meaningful consideration for long-term disease control.

The authors emphasized the need for HS-specific equivalence studies, as biosimilar approvals for adalimumab do not require clinical trials in HS and instead rely on extrapolation from psoriasis and other conditions. As biosimilar markets grow to include agents targeting interleukin-12/23 and interleukin-17 pathways, understanding how these products perform specifically in HS will be essential for optimizing care and informing future formulary policy.

Aghajani M, Pham J, Sholji T, Burrell K, Kok C, Frew JW. Originator versus biosimilar adalimumab in hidradenitis suppurativa: A multicenter real-world analysis of clinical response, maintenance of response, and switching. 

. 2025:24:9-15. doi:10.1016/j.jdin.2025.05.023

New research reveals that switching from originator to biosimilar adalimumab for hidradenitis suppurativa may lead to reduced treatment effectiveness and stability.

Real-World Data Highlight Adalimumab Biosimilar Options for Hidradenitis Suppurativa

 (pertuzumab-dpzb) injection, making it the first biosimilar approved for Perjeta (pertuzumab). Poherdy was also with interchangeability.

 This approval, granted to the product developed by Shanghai Henlius Biotech and commercialized by Organon, signals the expansion of biosimilar competition into the HER2-positive breast cancer treatment landscape.

FDA approves Poherdy, the first interchangeable biosimilar for Perjeta, enhancing competition in HER2-positive breast cancer treatment. | image credit: gustavofrazao - stock.adobe.com

Rationale for Approval and Approved Indications

The FDA’s decision to approve Poherdy was based on a comprehensive review of scientific evidence demonstrating that the product is highly similar to Perjeta and possesses no clinically meaningful differences in terms of safety and effectiveness. The evidence package included a detailed analytical comparison utilizing an extensive battery of physicochemical tests and biological assays across multiple manufactured lots, confirming similarity in structural and functional features known to impact safety and efficacy.

Clinical data supporting the approval included results from a human pharmacokinetic (PK) similarity study in healthy adult participants, which confirmed similar exposure between Poherdy and Perjeta after a single intravenous infusion. Additionally, data from a study involving patients with early HER2-positive and HR-negative breast cancer in the neoadjuvant setting supported Poherdy's approval as an interchangeable biosimilar.

Poherdy is a HER2/neu receptor antagonist that targets subdomain II of HER2, working in concert with trastuzumab to augment antitumor activity. It was approved for all the same treatment indications currently approved for Perjeta in adults, including:

Use in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer in adults who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment for adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (greater than 2 cm or node positive)

Use in combination with trastuzumab and chemotherapy as adjuvant treatment for adults with HER2-positive early breast cancer at high risk of recurrence.

Next Steps: Legal Battles and Market Dynamics

The approval of Poherdy thrusts its developers, Shanghai Henlius Biotech and Organon, into the familiar territory of patent litigation, mirroring patterns seen previously in the adalimumab, ustekinumab, and etanercept markets.

Genentech and Hoffman-La Roche, the originators of Perjeta, have already filed the first patent infringement case concerning the pertuzumab biosimilar against Shanghai Henlius Biotech and Organon.

 The complaint, filed in the US District Court of New Jersey, alleges that the proposed biosimilar could reasonably infringe on 24 patents related to Perjeta. Genentech is seeking multiple forms of relief, including judgments of infringement, preliminary and/or permanent injunctions, and damages. Such litigation frequently leads to delayed market launches and prolonged monopolies.

The broader oncology landscape is gearing up for a significant wave of biosimilar competition, with the market opportunity expected to reach approximately $25 billion by 2029.

 The success of new entrants like Poherdy will depend heavily on offering steep net price discounts to gain rapid payer and provider adoption, a strategy that drove successful uptake for earlier oncology biosimilars (referencing Herceptin, Rituximab, and Avastin).

Policy Ambiguity: Interchangeability and Draft Guidances

Poherdy's designation as the first interchangeable biosimilar for Perjeta carries significant policy weight, although its practical impact in oncology may be limited. Interchangeability allows for substitution at the pharmacy level without prescriber consultation, similar to generic drugs.

 However, laws regarding interchangeability have never restricted access to provider-administered biologics—which often includes many oncology treatments like Poherdy (an injection)—meaning patients receiving clinic-based therapies can already access biosimilars regardless of this status.

Meanwhile, policy surrounding biosimilar development and interchangeability remains in flux at the FDA level, with key draft guidances yet to be finalized.

 The FDA has released draft guidance suggesting that comparative efficacy studies may be waived for a biosimilar biologics license application if the product is analytically well-characterized, a move intended to trim development costs (estimated between $100 million and $300 million per program) and shorten timelines. 

Similarly, updated draft guidance on interchangeability proposes removing the requirement for expensive switching studies, citing emerging scientific consensus that switching risk is insignificant.

 These unfinalized guidances create potential confusion for manufacturers as they plan their subsequent launches. Furthermore, while federal officials have expressed strong political support for considering all biosimilars interchangeable, state laws requiring specific prescriptions or banning automatic substitution create ambiguity about the immediate practical effect of this designation across the country.

Remaining Challenges for Oncology Biosimilars

Despite the momentum generated by Poherdy's approval, the oncology biosimilar space faces several systemic challenges:

 A major long-term issue remains the "biosimilar void," where only about 10% of the biologics expected to lose patent protection between 2025 and 2034 have biosimilars in active development.

 This gap is driven by prolonged development timelines, manufacturing complexity, and limited return on investment for treatments targeting smaller patient populations.

 Even with lower list prices, the benefit of biosimilars may not reach patients due to prevailing rebate structures and reimbursement policies negotiated between pharmacy benefit managers (PBMs) and manufacturers.

 PBM policies often favor more expensive originator products, thereby inhibiting biosimilar uptake.

 Reference product manufacturers often deploy lifecycle management tactics, such as winning approval for new routes of administration or new indications, to protect exclusivity and limit the scope of biosimilar extrapolation on labels.

 The possibility of the US imposing tariffs on international pharmaceutical products and active pharmaceutical ingredients adds complexity, particularly since many biosimilars are developed by international companies.

The successful entry of Poherdy into the US market is a step forward for competition in oncology, putting pressure on reference product manufacturers like Roche.

 However, to realize the full potential of these treatments—including cost reductions and broader patient access—regulatory advancements must be paired with commercial reforms, litigation certainty, and stakeholder education to ensure long-term confidence in biosimilars.

1. FDA approves first interchangeable biosimilar to Perjeta to treat certain types of breast cancer. FDA. November 13, 2025. Accessed November 13, 2025. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilar-perjeta-treat-certain-types-breast-cancer

2. Yadav P, Corridon C, Mathuria M. The next frontier: oncology biosimilars in 2025 and beyond. The Center for Biosimilars

. January 13, 2025. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/the-next-frontier-oncology-biosimilars-in-2025-and-beyond

3. Genentech files first pertuzumab BPCIA complaint against Shanghai Henlius and Organon. 

. August 18, 2025. Accessed November 18, 2025. 

https://www.jdsupra.com/legalnews/genentech-files-first-pertuzumab-bpcia-3305474/

4. Poore D. Breaking down biosimilar barriers: interchangeability. The Center for Biosimilars. November 14, 2024. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-interchangeability

5. Jeremias S. A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars. October 30, 2025. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/a-closer-look-at-new-fda-guidance-removing-barriers-to-biosimilar-development

6. Jeremias S. FDA draft guidance removes switching study requirements for biosimilar interchangeability. The Center for Biosimilars. June 20, 2024. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/fda-draft-guidance-removes-switching-study-requirements-for-biosimilar-interchangeability

7. Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars. February 5, 2025. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars

8. Jeremias S. The age of adalimumab is upon us: how stakeholders can prepare. The Center for Biosimilars. June 28, 2023. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/the-age-of-adalimumab-is-upon-us-how-stakeholders-can-prepare

9. Jeremias S. The Trump administration’s drug price actions and why US prices are already sky-high. The Center for Biosimilars. May 17, 2025. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/the-trump-administration-s-drug-price-actions-and-why-us-prices-are-already-sky-high

FDA approves Poherdy, the first interchangeable biosimilar for pertuzumab (Perjeta), enhancing competition in HER2-positive breast cancer treatment.

FDA Approves Poherdy: First Interchangeable Biosimilar to Perjeta

GBW 2025 webinar

Health care systems around the world are facing increasing challenges—from rising costs to gaps in access. Biosimilar medicines offer a promising solution, helping make care more accessible, affordable, and sustainable for patients everywhere. These goals align closely with the United Nations’ Sustainable Development Goals for Health by 2030, and today’s discussion will explore how biosimilars can help make that vision a reality.

This webinar is part of the sixth Annual Global Biosimilars Week, running from November 3 to 7, 2025. The theme this year—“Biosimilars: A Wise Investment for Global Health”—perfectly captures the spirit of this conversation and the opportunities ahead.

, senior director of biosimilar policy and science at Medicines for Europe (moderator)

, global lead, Non-Communicable Diseases, PATH Coalition

, clinical pharmacist (Endocrine/Diabetes) at the Endocrine Institute at Hospital Putrajaya in Malaysia

, director of regulatory affairs at Sandoz Mexico

, director of thought leadership at IQVIA

, oncologist at the University Hospital Bristol NHS Foundation Trust in the UK

, senior advisor in the Division of Access To Medicines and Health Products (MHP) for the World Health Organization (not shown)

These were questions asked by the audience during the live broadcast of the webinar. The speakers provided responses after the webinar ended. Below are their responses and insights.

Are there examples of biosimilar-driven access improvements that could be replicated in other regions?

There are examples available in the IGBA Biosimilar Access Policy Blueprint (2021) as well as in IGBA Biosimilar Communication Resources (Module 5 - The benefits of biosimilar medicines). Translating the biosimilar availability opportunity into tangible access development is always a matter of policy framework and policy interventions that transform the cost-effectiveness gains into investment in better use of resources and more efficient processes.

The 2024 NCD Best Buys report aims at supporting WHO member states to prioritize and scale up the implementation of the most impactful and feasible interventions in the national context. Off-patent medicines, including biosimilar medicines, are part of the best buys. Could you tell us more about the overall progress so far to meet the 2030 goals? (Are we on course? Are we delayed?)

The target established by WHO is for 80% availability. While there has been movement, it is not even across all regions and also varies between the private and public sectors, with private sector availability being slightly higher. The ranges are 38-68% in the public sector and 42% to 77% in the private sector. Some of the challenges are high prices, where many countries pay higher amounts than the international reference price, including both acute and chronic conditions, and where also there is increasing dependency on out-of-pocket payments.

In Mexico, will the government be adopting a streamlined biosimilar development pathway that removes the requirement for phase 3 (comparative efficacy) studies?

Currently the requirements by the local rules include the requirement for clinical trials to demonstrate efficacy and safety. In Mexico, the biosimilars are called biocomparables. Below there is more detail about it.

In my experience, the requirements related to clinical trials are case-by-case; in the end, the opinion of the New Molecules Committee and Biotech Products Evaluation Subcommittee (NMC/BPES) will determine the specific requirements for approval of each biocomparable biotechnological medicine. This opinion is based on the documentation presented in the CTD modules 2, 3, 4, and 5. During my presentation, I also mentioned that for biosimilars, the presubmission meeting before NMC/BPES is mandatory.

For biosimilars, below I have described some preclinical and clinical requirements indicated in the local rules, but this can be extended case by case:

“...The application must include the documentation outlined in Sections I to IX of Article 177, as well as preclinical and clinical studies such as:

Any other studies determined by the Ministry, based on the opinion of the New Molecules Committee.”...

“...III. Reports of preclinical studies in animals must include comparative data between the reference biotechnological medicine and the biocomparable product. These studies must be conducted in relevant animal species and include, as determined by the New Molecules Committee:

Comparative pharmacokinetic study reports, when required by the Ministry, to demonstrate pharmacokinetic biocomparability between the biocomparable and reference products, based on key parameters.”...

How many biosimilar products have been approved through reliance pathways in Mexico so far?

This data is not available. However, in my presentation I mentioned that during almost 4 years the reliance applied to participate in tenders without MA issued by COFEPRIS, applicable only for tenders to supply public institutions Therefore, some products that participated with MA issued by recognized authorities could be identified during the tender processes (small molecules and biosimilars), but there is no official data about the total number of biosimilar products approved through reliance pathways.

In the future, probably based on the last publication in July 2025, for the application of the abbreviated regulatory pathway (equivalence agreements), the approvals might be differentiated.

Regulatory convergence is improving among EMA, FDA, and WHO, but not all dossiers will meet these new standards.Will companies need to conduct new studies, and how might that affect costs or timelines?

 entitled “Developing a Regulatory Policy Framework Supporting Biosimilar Competition: The Opportunity for Tailored Clinical Biosimilar Development” where 2 important points were made:

A global regulators roadmap towards streamlined biosimilar development program should be adopted - maintaining the scientific and regulatory rigor is needed to support approval, and allow for tailored clinical development.

The role of regulators extends beyond approval to include education for healthcare professionals to understand the analytical science that underpins biosimilarity, ensuring that regulatory approval translates to utilization of biosimilar medicines.

Today, in 2025, both remain cornerstone to harvesting the benefits of streamlined development. The asynchrony of adoption of the new standards will require developers to at best maintain extended developments (including unnecessary studies) or worst to have 2 developments for the different jurisdictions, although this is unlikely to be retained as a viable option. This points to all international regulatory convergence initiatives (eg, ICH, IPRP, ACCESS consortium) as key drivers for access.

A significant evolution of the regulatory requirements in underway in the global regulatory community (so called streamlined clinical development) offering the perspective of biosimilar developments for more biologic medicines. How can the WHO efforts be amplified, notably in promoting harmonisation of standards (through the guidelines and their implementation) or through collaborative or reliance initiative?

: If anyone is not familiar with the WHO Prequalification of medicines programmes, I would strongly encourage them to spend some time reviewing the resources and information on the Prequalification website as I am personally on the policy side of the Health Systems Division. In the space of collaboration, the Prequalification programme runs the Collaborative Registration Procedure (CRP) for medicines, vaccines and health products that have been prequalified by WHO. The CRP allows for participating regulators to request, with participation of the manufacturer, the reports and information that were submitted to WHO for regulation for use in considering national market authorizations.

In addition, the concept of regulatory reliance is also advancing through the use of a global benchmarking tool, where countries will be able to develop reliance schemes-based products manufactured under the supervision of recognized regulator. WHO also supports the implementation of WHO biosimilars guidelines in Member States. From November 26 to November 28 in Tunis, WHO will host an implementation workshop for regulators from Africa and the Eastern Mediterranean region, where experience and regulatory frameworks for biosimilars are still developing. This initiative is part of WHO’s ongoing work to promote harmonization and strengthen regulatory capacity globally.

How can we maintain industry sustainability if biosimilar medicines prices drop very quickly in multiple regions?

 Sustainability of the biosimilar business is linked to the overall functioning of the framework: there are many variables. Market competition is an inherent part of the follow-on medicines’ business. The starting points for all biosimilar medicines benefit is to have a multisource market where biosimilar medicines are used, and uptake is significant.


Are African CDC–equivalent agencies considering adding biosimilar medicines into pooled procurement mechanisms?

With the creation of the African Medicines Agency and the pilot 

, there are opportunities for biosimilar medicines developers with biosimilar medicines recognized under the Priority Medicinal Products Category 1 of interest besides facilitating national authorization of the products and strengthening the regulators network, this will without any doubt support translation of approvals into actual market uptake.

WHO is investing in good practice sharing for procurement among WHO member states yet, it feels that there remains an awareness gap among procurers, assimilating biosimilar medicines with generic medicines. This can lead to an impossible match between demand and supply. What can be done to bridge this gap?

 WHO is, as we are speaking today, convening a Forum for procurers to consider priority best practices for the future. Ensuring quality of medicines using procurement as a lever is one area that has already emerged as a priority.

Another one is transparency into markets, which has a benefit for buyers and also for sellers. The more transparent tender information becomes, for example, the more sources the buyer will be able to attract. Sellers also benefit from improved visibility into markets, which we have understood anecdotally is a challenge in the NCD space. Developing pooled procurement mechanisms is also an area that can supply market entry, which is important in the uptake of biosimilar medicines.

It’s great to hear examples of improved access—but why isn’t this type of data more often published in peer-reviewed journals?

 an interesting example of improved and early access is that of a Dutch Research Team lead by Lizzy De Ridder in the context of the 

. The study aimed at making better use of the available treatments for children living with inflammatory bowel disease by changing the treatment paradigm and initiate treatment with the biologic therapy (rather than conventional treatment involving enteral nutrition and corticosteroid therapy). The use of first line infliximab therapy led of significant clinical and endoscopic remission for the children involved (ie, improved health outcomes, disease management and quality of life).

Biosimilar manufacturers have published numerous studies demonstrating clinical equivalence, yet there are far fewer publications from health systems showing real-world benefits—such as increased or earlier patient access and how savings are being reinvested into care. How can we encourage more transparency and data sharing from health systems?

 Regulators have the possibility to publish reviews of pharmacovigilance data on a regular basis. While the absence of ‘unexpected issues’ maybe unattractive for publishers, it has the merit of reinforcing the robustness of the regulatory system, its standards and the compliance to them. In Europe, there have been 2 such reviews supporting the confidence of healthcare professionals and patients.

2013: Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases. Drug Saf. 2013 Aug;36(8):617-25. doi: 10.1007/s40264-013-0073-3.

2015: Traceability of biologicals: present challenges in pharmacovigilance Expert Opin Drug Saf. 2015 Jan;14(1):63-72. doi: 10.1517/14740338.2015.972362. Epub 2014 Nov 5.

2019: Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice doi:10.1002/cpt.1310

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The competitive landscape for biosimilar therapies targeting bone health and cancer-related skeletal events shifted markedly in fall 2025, as the FDA approved multiple denosumab biosimilars and issued 2 new interchangeability designations—signaling continued momentum in an increasingly crowded therapeutic space.

FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies. | Image Credit: Nasr - stock.adobe.com .jpeg

The FDA approved several denosumab biosimilars referencing Prolia (for osteoporosis and bone loss) and Xgeva (for prevention of skeletal-related events in cancer) throughout 2025, with a surge of activity in the fall months.

In September 2025, the agency approved Hikma Pharmaceuticals/Gedeon Richter’s Enoby and Xtrenbo (denosumab-qbde), followed by approvals of Accord Healthcare’s Osvyrti and Jubereq (denosumab-desu) in October.

These approvals represented a significant diversification in available denosumab options for both postmenopausal osteoporosis and oncology indications. Collectively, the biosimilars are expected to improve patient access and introduce pricing competition in a therapeutic area that has historically faced high treatment costs and limited alternatives.

Interchangeability for More Denosumab Products

Alongside the new approvals, the FDA formally granted the interchangeability (IC) designation to 2 pairs of denosumab biosimilars in late October 2025—a regulatory milestone allowing pharmacists to substitute these products for their reference biologics without prescriber approval, subject to state laws.

On October 29, 2025, Fresenius Kabi announced that its products Conexxence and Bomyntra were designated as interchangeable biosimilars to Prolia and Xgeva, respectively.

 Conexxence is indicated for adults at high risk for fracture, including individuals with osteoporosis, while Bomyntra is approved to prevent skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors.

One day later, Celltrion announced the same designation for 

 (denosumab-bmwo), which are also interchangeable with Prolia and Xgeva across all approved indications.

 These designations were supported by analytical and comparative clinical data—including pharmacokinetic, safety, and immunogenicity results from studies in postmenopausal women with osteoporosis—demonstrating no clinically meaningful differences from their reference products.

According to Celltrion, the interchangeability status underscores the company’s commitment to expanding access to affordable biologic therapies while maintaining rigorous evidence-based standards for biosimilarity.

Designations Continue Amid Policy Confusion

The FDA’s decision to continue granting interchangeability designations came just weeks after federal officials publicly stated that all biosimilars should be considered interchangeable—a move that generated both optimism and confusion across the health care sector.

At an October 2025 press conference introducing new FDA draft guidance, HHS Secretary Robert F. Kennedy Jr, FDA Commissioner Marty Makary, MD, and Mehmet Oz, MD, asserted that “all biosimilars are interchangeable” with their reference products.

 The officials framed this position as an effort to streamline access, reduce costs, and encourage automatic pharmacy substitution, urging state governors to promote biosimilar adoption.

However, despite these declarations, the FDA has not officially retired the formal interchangeability designation process. The October approvals demonstrate that the agency continues to issue designations based on submitted evidence, consistent with statutory requirements under the Biologics Price Competition and Innovation Act.

Although the FDA’s recent draft guidance allows manufacturers to use existing Biologics License Application data to support interchangeability requests—reducing the need for costly switching studies—the broader legal framework for biosimilar substitution remains unresolved.

Officials have not clarified whether state-level restrictions on automatic substitution will be overridden by federal guidance. Currently, 4 states and Puerto Rico prohibit automatic biosimilar substitution, and many others require prescriber or patient notification. Without explicit federal preemption, the practical impact of “universal interchangeability” claims remains uncertain for pharmacy-dispensed biologics.

The denosumab approvals and interchangeability decisions align with the FDA’s ongoing efforts to modernize biosimilar development. The agency’s updated draft guidance—

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies

—emphasizes advanced analytical methods over routine comparative efficacy trials. This approach is intended to shorten development timelines and reduce program costs, historically estimated at $100 million to $300 million per biosimilar.

FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies.

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