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

Skylar Jeremias

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

The Center for Biosimilars is a media partner for Global Biosimilars Week.

Videos

Webinar: Aligning Biosimilar Access Policy With Global Health Priorities

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.

For managed care stakeholders, these regulatory and policy shifts may offer faster, more cost-effective biosimilar entry into the US market. Yet, experts caution that the full benefits of these reforms will depend on broader systemic alignment—addressing persistent challenges such as manufacturing complexity, payer incentives, and pharmacy benefit manager transparency.

Despite progress, analysts warn that a “biosimilar gap” persists: only about 10% of biologics expected to lose exclusivity between 2025 and 2034 currently have biosimilars in active development. As denosumab biosimilars continue to reach the market, sustained collaboration among regulators, manufacturers, and payers will be key to achieving long-term affordability and access in biologic care.

1. Biosimilar approvals. The Center for Biosimilars

. Updated November 12, 2025. Accessed November 13, 2025. 

https://www.centerforbiosimilars.com/biosimilar-approvals

2. FDA grants interchangeable designation to Fresenius Kabi’s biosimilars Conexxence and Bomyntra (denosumab-bnht). News release; Fresenius Kabi. October 29, 2025. Accessed November 13, 2025. 

https://www.fresenius-kabi.com/us/news-and-events/interchangeable-designation-granted-conexxence-bomyntra

3. U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo). News release; Celltrion. October 30, 2025. Accessed November 13, 2025. 

https://www.prnewswire.com/news-releases/us-fda-grants-interchangeability-designation-to-celltrions-denosumab-biosimilars-stoboclo-denosumab-bmwo-and-osenvelt-denosumab-bmwo-302599537.html

4. Jeremias S. A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars. October 30, 2025. Accessed November 13, 2025. 

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

Articles

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

FDA Quietly Approves Denosumab Biosimilars, Issues Interchangeability for Others

Not all adalimumab biosimilars are created equal when it comes to formulation design, injection devices, and patient support services—differences that may affect comfort, adherence, and access for individuals using these therapies around the world, according to a new international analysis.

, compared adalimumab biosimilars and the originator Humira across 9 countries. The authors said the goal was to help prescribers navigate a growing number of products that are clinically comparable but differ in nonpharmacologic features that can shape patient experience.

Explore the diverse landscape of adalimumab biosimilars, focusing on formulation, devices, and patient support programs that enhance treatment experiences. | Image Credit: hamkin - stock.adobe.com

Patent Expirations Drive Rapid Market Expansion

Humira, a fully human monoclonal antibody that inhibits tumor necrosis factor (TNF)–α, was first approved by the FDA in 2002 for rheumatoid arthritis and later for Crohn disease and ulcerative colitis. Global patents for the product began expiring in 2018 in Europe and Australia and in 

, paving the way for what experts hoped would be a surge in biosimilar competition.

The research team gathered information from global medication registries and regulatory agencies, including the FDA, European Medicines Agency, and Health Canada, as well as authorities in Australia, India, Singapore, and the UK.

 Data were supplemented with responses from pharmaceutical manufacturers and expert insights from gastroenterologists in each participating country.

By late 2024, more than 20 adalimumab biosimilars had entered markets worldwide. The study examined 14 products in detail: 13 biosimilars and the originator Humira. Data collection concluded in September 2024, with analysis focusing on device characteristics, formulation type, and the breadth of available patient support systems.

While all products share comparable efficacy and safety with the originator, the authors noted that subtle distinctions—such as excipient composition, device usability, and availability of patient support—may meaningfully impact patient satisfaction and persistence on therapy.

In total, 29 adalimumab products were identified worldwide, though many were marketed only in limited regions or lacked publicly available information. Among the 14 analyzed in depth, the authors reported notable variation in device and formulation features.

All products were available as either prefilled syringes (PFS) or auto-injectable pens (AIPs), with AIPs incorporating retractable needles to reduce needlestick risk. Most devices used 29-gauge needles, although Amgevita and Cyltezo prefilled syringes used slightly larger 27-gauge needles.

Injection mechanisms also differed: some pens delivered the drug in 2 steps, while others required a third button-press step, which could affect usability for individuals with limited dexterity.

Concentration and excipient profiles varied across brands. Several newer biosimilars—such as Yuflyma, Hukyndra, and Cyltezo—offered high-concentration (100 mg/mL), citrate-free formulations that may reduce injection volume and site discomfort. Older products, including Humira and Hadlima, retained citrate in small amounts.

Shelf life and storage flexibility also distinguished products. Imraldi offered the longest refrigerated shelf life (42 months), while Yuflyma, Abrilada, Hukyndra, and Xelenka could be stored at room temperature for up to 30 days. Humira and several others lasted only 14 days outside refrigeration. All reviewed products were latex-free except for certain versions of Cyltezo and Amgevita.

Stronger Patient Support Programs in Australia, Canada, and the US

Patient support program (PSP) availability differed significantly between countries. Programs in Australia, Canada, and the United States were the most comprehensive, often providing 1-on-1 injection training, educational videos, help hotlines, and adherence reminders.

Some manufacturers also offered additional resources. In Australia, for example, Idacio patients could access online cognitive behavioral therapy modules, and Humira users were eligible for personalized health coaching calls covering nutrition or lifestyle goals. Amgevita and Hadlima offered both digital reminders and refill notifications, while all major products in Australia provided sharps containers and travel packs.

In contrast, PSPs in India, Japan, and Portugal were less standardized and sometimes limited to online informational portals or printed materials. The authors noted that these disparities may affect how confident and supported individuals feel when starting biologic therapy.

The investigators acknowledged that not all manufacturers responded to data requests, particularly those marketing products exclusively in India and other emerging markets. Additionally, the analysis focused on product attributes and support programs rather than clinical or adherence outcomes, limiting conclusions about how these features affect real-world use.

The study’s authors emphasized that although all adalimumab biosimilars are designed to be therapeutically equivalent, their practical differences matter. Formulation concentration, injection ease, storage requirements, and patient education resources can influence both provider preference and patient adherence.

“Adalimumab biosimilars have various strengths and weaknesses, and no single product is perfect for every patient,” the researchers wrote. “It’s important to choose a product that fits each patient’s individual needs and healthcare situation.”

As biosimilar competition continues to expand globally, the combination of usability, convenience, and patient support may become an increasingly important differentiator in long-term adoption.

1. Yiu TH, Anderson E, Leung WK, et al. Adalimumab around the world: comparative analysis of products characteristics and patient support systems. 

 Published online October 5, 2025. doi:10.1177/17562848251358168

2. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars

. January 31, 2024. Accessed November 5, 2025. 

https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

New findings explore the adalimumab biosimilar landscape, focusing on formulation, devices, and patient support programs that enhance treatment experiences.

Global Data Show Variety in Adalimumab Biosimilar Design, Patient Support Systems

October 2025 proved to be a pivotal month for the biosimilar landscape, featuring monumental US policy shifts designed to dramatically accelerate development and unlock billions in cost savings, while simultaneously reinforcing the crucial role of biosimilars in enhancing global health system resilience and solidifying market growth through both key product approvals and real-world clinical data. 

October 2025 marks a transformative period for biosimilars, with new FDA guidelines accelerating approvals and promising significant cost savings for health care.

Managed care organizations are now evaluating the long-term impact of accelerated regulatory pathways alongside concrete data proving product viability in clinical settings worldwide.

FDA Paves Way for Streamlined Biosimilar Approvals

The FDA issued new draft guidance that stakeholders believe could significantly accelerate the entry of biosimilars into the American market, potentially unlocking substantial cost savings for the health care system.

," updates 2015 recommendations by outlining criteria for waiving the often-costly and time-consuming comparative efficacy study (CES) requirement for biologics license applications (BLAs) under section 351(k).

Historically, CESs have been a significant bottleneck, financially and logistically, in biosimilar development. The new framework emphasizes that advanced analytical technologies are now often more precise at detecting minor differences between highly purified proteins than clinical trials, whose outcomes can be affected by factors like patient variability.

Under the updated criteria, a CES may be waived if the biosimilar and reference product are highly purified and well-characterized analytically; if key quality attributes of the reference product are well understood and measurable via comparative analytical assessment; and if a human pharmacokinetic similarity study is feasible and clinically meaningful. By shifting focus from routine CESs to analytical studies, the FDA aims to reduce development expenses—estimated between $100 million and $300 million per program—and shorten development timelines by several years.

Policy leaders praised the move, with HHS Secretary Robert F. Kennedy Jr stating the guidance replaces “bureaucracy with science, monopolies with competition, and despair with hope.” 

Projections suggest that this new framework could help unlock an additional $181 billion in US savings over the next five years, building on the $56 billion already generated by biosimilars.

Despite the enthusiasm, uncertainty remains regarding interchangeability. While officials suggested that all biosimilars should be considered interchangeable to promote automatic substitution, existing laws in 4 states and Puerto Rico currently prohibit automatic substitution, requiring explicit prescriptions. These substitution bans, or the total absence of federal preemption, create ambiguity regarding the immediate practical effect of the federal guidance claims.

Biosimilar Void Persists Despite Regulatory Boost

Even with momentum from the FDA, the “biosimilar void” continues to challenge future market growth. According to industry data, 118 biologics, representing nearly $232 billion in US sales, are expected to lose patent protection between 2025 and 2034, yet only about 10% of these have biosimilars in active development.

This gap is driven by factors including limited return on investment for rare-disease products, the complexity of manufacturing advanced biologics, prolonged development timelines, and market uncertainty stemming from the Inflation Reduction Act. Stakeholders are warned that development efficiencies must be paired with improved commercial viability for cost savings to materialize.

Global Perspective: Biosimilars Drive Health System Resilience in LAC

The transformative role of biosimilars extends beyond US borders, as highlighted by a narrative review focusing on Latin American and Caribbean (LAC) nations.

, concluded that biosimilars possess the potential to enhance patient access drastically and ensure long-term sustainability for regional health systems.

The review addressed the prohibitive expense of original biologic therapies in low- and middle-income LAC regions, which has created deep disparities in access to care for complex and chronic conditions like cancer and autoimmune diseases. The authors identified 4 primary economic levers activated by biosimilar introduction: cost reduction, access expansion, market competition, and relief of financial pressure on public sector budgets. 

Successful adoption, the authors noted, is fundamentally an issue of health equity and long-term economic stability. However, realizing the full potential depends on the successful implementation of necessary regulatory enhancements and education initiatives across the region’s highly variable and fragmented markets.

Ophthalmology Market Sees Key Approval and Stability Data

In the realm of product news, the FDA approved Celltrion’s Eydenzelt (aflibercept-boav) in October 2025, an aflibercept biosimilar referencing Eylea.

 This marks Celltrion’s first FDA-approved biologic in ophthalmology and is the sixth aflibercept approval in the US. 

Eydenzelt was approved for treating retinal diseases, including neovascular age-related macular degeneration and diabetic macular edema (DME). The approval was based on clinical data, including a 52-week phase 3 study in patients with DME that met predefined equivalence criteria compared to the reference product.

Furthermore, critical data emerged supporting the logistical viability of existing ophthalmic biosimilars. A study confirmed the extended stability of XSB-001 (Ximluci), a ranibizumab biosimilar used for retinal conditions, under real-world clinical handling conditions. These findings reinforce the utility of XSB-001 in managed care settings by proving the drug's integrity withstands the practical demands of preadministration storage.

A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars

. October 30, 2025. Accessed November 5, 2025. 

Biosimilars improve health system resilience in Latin American, Caribbean nations. The Center for Biosimilars. October 28, 2025. Accessed November 5, 2025. 

https://www.centerforbiosimilars.com/view/biosimilars-improve-health-system-resilience-in-latin-american-caribbean-nations

Real-world stability confirmed for Biosimilar Ximluci in prefilled syringes. The Center for Biosimilars. October 9, 2025. Accessed November 5, 2025. 

https://www.centerforbiosimilars.com/view/real-world-stability-confirmed-for-ranibizumab-biosimilar-ximluci-in-prefilled-syringes

FDA approves Celltrion aflibercept biosimilar: Eydenzelt. The Center for Biosimilars. October 13, 2025. Accessed November 5, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-celltrion-aflibercept-biosimilar-eydenzelt

Biosimilar Monthly Roundup: October 2025

Demonstrating treatment consistency over a full year, the latest clinical data confirmed that the ustekinumab biosimilar Bmab 1200 was equivalent to the reference product in treating moderate to severe plaque psoriasis.

 successfully demonstrated that Bmab 1200, a biosimilar candidate referencing ustekinumab, showed equivalent efficacy, comparable safety, and a similar immunogenicity profile to the reference product over 52 weeks in adults with moderate to severe chronic plaque psoriasis. The data package supported the use of Bmab 1200 as an alternative treatment option, including for people who transitioned from the reference ustekinumab.

The primary objective of the STELLAR-2 trial was to meet regulatory requirements by establishing the equivalent efficacy of Bmab 1200 and the reference ustekinumab (Stelara). This randomized, double-blind, active-controlled study was essential for confirming biosimilarity following extensive analytical and pharmacokinetic comparisons.

New clinical data confirms Bmab 1200, a biosimilar to ustekinumab, offers equivalent efficacy and safety for treating moderate to severe plaque psoriasis. | Image Credit: SNAB - stock.adobe.com

The study included a crucial re-randomization step at week 16. After an initial treatment period (TP1) where people received either Bmab 1200 or reference ustekinumab, responders in the reference ustekinumab arm were re-randomized to either continue the reference product or switch to Bmab 1200 for the remainder of the study (TP2), allowing for an evaluation of safety and efficacy after transition.

The study tracked 384 adult patients. The primary efficacy endpoint was the percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score at week 12. Bmab 1200 met the predefined equivalence margin, confirming initial therapeutic similarity.

52-week Data on Efficacy: The 52-week findings confirmed consistent treatment responses across all cohorts. The mean percentage reduction in PASI scores from baseline was highly consistent at the final assessment:

Reference Ustekinumab (continued): –96.6%

Switched-to-Bmab 1200 (at week 16): –94.7%

These results affirmed that the efficacy was maintained through one year, even following the switch from the reference drug to the biosimilar. Secondary efficacy endpoints, including the Physician’s Global Assessment and Dermatology Life Quality Index scores, also showed comparable improvements.

Safety and Immunogenicity: The safety profile of Bmab 1200 was consistent with the known profile of the reference product. The incidence of treatment-emergent adverse events (TEAEs) and their severity were similar across treatment groups. Crucially, the immunogenicity profile, indicated by the incidence of anti-drug antibodies (ADAs), was also comparable after the switch.

The authors noted the clinical relevance of the comprehensive data package, stating, "The study reinforces the confidence we can have in the biosimilar regulatory pathways and the principles they are built on. Specifically, for Bmab 1200, the study shows that it offers an effective, safe, and comparable alternative to reference ustekinumab."

The STELLAR-2 trial enrolled 384 adult participants diagnosed with moderate to severe chronic plaque psoriasis. The inclusion criteria required people to be 18 years of age or older with defined disease severity metrics (eg, specific PASI score and affected body surface area). The study was conducted as a multinational, multicenter trial.

Standard limitations applicable to this phase 3 trial included:

Limited Long-Term Follow-Up: The study duration was 52 weeks. Further long-term data would be beneficial for chronic conditions requiring indefinite treatment.

Specific Patient Population: The trial was limited to people with moderate to severe plaque psoriasis, and the results require extrapolation to cover the other ustekinumab indications (eg, Crohn disease or psoriatic arthritis).

Controlled Setting: As a clinical trial, the results represented a controlled patient environment and may vary slightly in broader real-world populations with more diverse comorbidities.

In summary, the STELLAR-2 trial successfully confirmed that Bmab 1200 was highly similar to reference ustekinumab in terms of efficacy, safety, and immunogenicity over 52 weeks, supporting its clinical use across all tested cohorts, including those who transitioned treatment.

Szepietowski JC, Reich A, Feldman SR, et al. Comparative efficacy and safety of biosimilar Bmab 1200 versus reference ustekinumab in moderate-to-severe plaque psoriasis: 52-week findings from the phase 3 STELLAR-2 trial. Expert Opin Biol Ther. Published online October 21, 2025. doi:10.1080/14712598.2025.2576506

New clinical data confirms Bmab 1200, a biosimilar to ustekinumab, offers equivalent efficacy and safety for treating moderate to severe plaque psoriasis.

Data Confirm Biosimilar Bmab 1200 Performance in Psoriasis Through 1 Year

To address growing uncertainty over JC virus (JCV) antibody testing for patients receiving the natalizumab biosimilar Tyruko, a group of UK neurologists has published new recommendations in 

 The consensus statement provides a framework for interpreting JCV results and managing progressive multifocal leukoencephalopathy (PML) risk amid reports that the assays used for biosimilar monitoring may yield differing results from those historically used with the originator drug, Tysabri.

UK neurologists release new guidelines for JCV testing in patients using the natalizumab biosimilar Tyruko, addressing safety and monitoring challenges. | Image credit: millaf - stock.adobe.com

The discussion around the rollout of Tyruko and the challenges in aligning testing protocols comes as the global community observes 

, an annual initiative highlighting the importance of expanding access to safe, effective, and affordable biologic therapies.

 The UK experience with natalizumab biosimilar testing underscores how the practical details of biosimilar implementation—such as laboratory assay consistency—play a critical role in ensuring that these therapies meet their promise of broader access while maintaining patient confidence and safety.

Reference natalizumab (Tysabri) is a well-established therapy for individuals with rapidly evolving severe multiple sclerosis (MS). The biosimilar version, Tyruko, was approved by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) following evidence demonstrating equivalent efficacy and safety. Its introduction is expected to deliver cost savings and improve treatment access across the National Health Service (NHS).

However, a new challenge has emerged in the transition from the reference product to its biosimilar counterpart. JCV antibody testing, which is required for all patients receiving natalizumab due to the therapy’s risk of PML, has historically been conducted using Biogen’s 

 assay. For those receiving Tyruko, JCV status is now determined using Sandoz’s 

 assay, and studies have shown that the 2 tests may not always agree.

According to the researchers from Queen Mary University of London, “The Immunowell test appears more likely to report a positive JCV index compared with the Stratify assay.” While negative results between the 2 assays generally align, early data show that roughly 41% of patients have been reclassified from JCV-negative to JCV-positive when switching assays. This is a sharp contrast to the typical 3% to 6% annual seroconversion rate seen with Stratify alone.

This finding has implications for both clinical practice and patient well-being. People identified as JCV-positive are typically considered at higher risk of developing PML, which can prompt clinicians to shorten treatment duration, increase magnetic resonance imaging (MRI) monitoring frequency, or recommend alternative disease-modifying therapies. “There remains a real risk that a proportion of patients will be inappropriately classified as being at higher risk of PML, and therefore denied the option of natalizumab, a highly effective therapy, or undergo unnecessarily burdensome monitoring, with resultant cost to the NHS and anxiety,” the authors wrote.

To help clinicians navigate these discrepancies, the group developed an interim set of principles for interpreting 

 results. The recommendations vary depending on whether a patient is new to natalizumab or switching from the reference product.

For treatment-naive patients starting on Tyruko, those with negative Immunowell results can be monitored using standard NHS protocols. Patients testing positive can generally proceed with therapy, particularly during the first 2 years, if risk is regularly reassessed and plans are made to transition or reduce risk exposure after 12 to 24 months. Extended-interval dosing or increased MRI monitoring may also be considered as risk-mitigation strategies, though supporting evidence remains limited.

For individuals transitioning from Tysabri to Tyruko, the panel advised that low-positive results on Immunowell should be interpreted cautiously, as short-term risk is unlikely to have changed significantly. Persistently positive or rising JCV indices after 6 months may, however, justify treatment review or modification after 12 to 24 months. Patients whose Immunowell results show unexpectedly high JCV indices should be counseled about the possibility of increased risk, though the authors noted that this remains “an area of clinical uncertainty.”

The statement emphasized that transparent communication between clinicians and patients will be key to maintaining trust as these testing transitions continue. “To maintain confidence in treatment decisions, shared decision-making is essential, including openly discussing both the benefits and risks of therapy,” the authors wrote.

The authors also pointed to broader structural issues in how biosimilars are integrated into health care systems. Because JCV testing is tied to proprietary pharmaceutical company assays, differences in available testing methods can create inconsistencies when switching to a biosimilar. The authors argued that “a publicly developed, standardized JCV assay would ensure uniform, reliable results across biosimilar preparations,” a step they say would promote equitable access and ensure consistent safety monitoring.

The statement’s limitations reflect the current lack of longitudinal data connecting Immunowell results to PML outcomes. Given the rarity of PML, building such evidence will take years. Until then, the authors recommend caution in directly applying existing Stratify-based risk models to Immunowell data, as this could overestimate risk and undermine confidence in biosimilar safety.

Despite these uncertainties, the authors reaffirmed their support for biosimilars as a path toward a more sustainable and accessible health care system. “Biosimilars offer an opportunity for more cost-effective health services, but their rollout has the potential to highlight vulnerabilities in service delivery models,” they concluded. “It is incumbent on regulators, pharmaceutical companies, clinical teams, and commissioning bodies to work together to ensure ongoing access to a highly effective therapy while maintaining patient safety.”

As Global Biosimilars Week spotlights efforts to increase biosimilar adoption and understanding worldwide, the UK’s experience with natalizumab biosimilar testing serves as a reminder that successful implementation requires not only regulatory approval and pricing reform but also consistent, evidence-based clinical tools to guide patient care.

Dobson R, Arun T, Varley J, et al. Approach to JCV testing with natalizumab biosimilar: a UK consensus statement. 

. Published online August 2025. doi:10.1016/j.msard.2025.106541

Global Biosimilars Week. Event official website. Accessed November 4, 2025. https://globalbiosimilarsweek.org/2025/

UK neurologists release new guidelines for JC virus testing in patients using the natalizumab biosimilar Tyruko, addressing safety and monitoring challenges.

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