Christina Mattina

 (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

Articles

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

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.

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

," 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

The FDA has issued draft guidance that stakeholders say could significantly accelerate the entry of biosimilars into the US market, potentially unlocking substantial cost savings for the health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

," outlines updated criteria for when a comparative efficacy study (CES) may not be necessary for a biologics license application (BLA) submitted under section 351(k) of the Public Health Service Act. This update supersedes the agency’s 2015 guidance and reflects its evolving scientific approach to biosimilar evaluation.

By prioritizing analytical studies, the FDA aims to reduce both the time and cost of biosimilar development. | Image credit: Postmodern Studio - stock.adobe.com

Shifting From Clinical Trials to Analytical Science

Historically, biosimilar development has been slowed by complex, costly 

. CESs, in particular, have represented a significant bottleneck—both financially and logistically.

The FDA’s draft guidance emphasizes that advanced analytical technologies can now detect minor differences between highly purified proteins more precisely than clinical trials.

 A well-conducted comparative analytical assessment (CAA) is often more sensitive than a CES, whose outcomes may be affected by factors such as dose selection, patient population variability, or trial design.

Under the new framework, a CES may be waived if:

The biosimilar and reference product are highly purified, derived from clonal cell lines, and analytically well characterized

Key quality attributes of the reference product are well understood and measurable via CAA

A human pharmacokinetic (PK) similarity study is feasible and clinically meaningful

By prioritizing analytical studies over routine CESs, the FDA aims to reduce both the time and cost of biosimilar development—potentially trimming expenses estimated between $100 million and $300 million per program and shortening development timelines by several years.

Policy Leaders Highlight Potential Savings

The draft guidance has drawn praise from policy makers and industry advocates. 

 described previous regulatory requirements as burdened by “sky-high costs [and] endless red tape,” stating that the guidance replaces “bureaucracy with science, monopolies with competition, and despair with hope.”

FDA Commissioner Marty Makary, MD, emphasized that removing unnecessary barriers could expand competition, lower biologic prices, and improve patient access. Similarly, 

 called the guidance “momentous” in addressing the US prescription drug affordability crisis.

 Executive Director Juliana M. Reed noted, “Now more than ever, it is clear that biosimilars—

safe, effective, and lower-cost medicines that reference biologics

—are key to fixing America’s healthcare affordability crisis. 

 say they have not taken their medication as prescribed due to unaffordable prices. Today’s updated guidance from the FDA and Commissioner Makary on biosimilars is a momentous, critical step in unlocking the potential of these modern treatments to lower prescription drug prices for all Americans.”

Reed also highlighted that biosimilars have already generated over $56 billion in US savings and that the new framework could unlock an additional $181 billion over the next 5 years.

Robert F. Kennedy Jr (left), Marky Markary, MD (center), and Mehmet Oz, MD (right), at the press conference announcing the new biosimilar guidance.

At the press conference announcing the draft guidance, the policy makers repeatedly emphasized that all biosimilars should be considered interchangeable with their reference products.

 They suggested this designation would allow pharmacists to automatically substitute biosimilars and encouraged state governors to actively promote biosimilar use, framing interchangeability as a key tool to expand access and reduce costs.

The officials did acknowledge that some states require notification to patients or providers when a biosimilar substitution occurs. However, they did not address portions of the country that maintain total bans on substitution, nor clarify whether these laws would be considered void under the new federal guidance. As 

previously reported by The Center for Biosimilars

, 4 states and Puerto Rico currently prohibit automatic biosimilar substitution, requiring prescriptions to explicitly name the biosimilar.

 Without federal preemption or updated state legislation, it remains uncertain how these restrictions would interact with the federal guidance, creating ambiguity about the practical effect of the press conference claims.

Previously, a biosimilar can carry the FDA’s interchangeability designation only if the manufacturer requests it and provides additional evidence demonstrating that the biosimilar produces the same clinical result as the reference product in any given patient, and that switching between the products poses no additional risk. Additionally, interchangeability typically applies only to pharmacy-dispensed biologics, typically self-administered therapies such as adalimumab or insulin in which a provider is not present for the substituion. Laws around interchangeability have never restricted access to 

, meaning patients receiving clinic-based therapies—including many oncology treatments—continue to access biosimilars regardless of interchangeability status.

Thus, while the statements from Kennedy, Makary, and Oz conveyed strong political support for biosimilars, they may overstate the immediate practical impact, particularly in jurisdictions with restrictive substitution laws or total bans, or for patients receiving clinic-administered biologics.

Despite regulatory momentum, the so-called biosimilar void remains a critical challenge. According to Samsung Bioepis, 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.

Limited return on investment for niche or rare-disease products:

 Manufacturers hesitate to invest heavily in biosimilars for small patient populations

 Advanced biologics—such as bispecific antibodies or cell-based therapies—require specialized facilities and expertise

 Even with streamlined guidance, bringing a biosimilar to market can take nearly a decade

Market uncertainty under the Inflation Reduction Act:

 have created new disincentives for some biosimilars, particularly those approaching Medicare negotiation windows.

Without additional reforms—such as addressing rebate structures, patent thickets, prescriber incentives, biosimilar education gaps, and pharmacy benefit manager transparency—the US may not realize the full potential of biosimilar competition.

Additionally, many biosimilars are developed by international companies that have licensing and commercialization agreements with larger American-based companies. With the Trump administration's previous statements about potentially placing 

tariffs on international pharmaceutical products

 and initiatives to bring more pharmaceutical manufacturing into the US, it's uncertain if there will be unintended interactions between policies that may create new barriers to bringing biosimilars to market.

Implications for Managed Care and Patient Access

For managed care executives, payers, and provider systems, the FDA’s draft guidance represents a critical step toward faster, more cost-effective biosimilar entry. However, the benefits of these reforms could take years to materialize, underscoring that policy change alone will not close the biosimilar void.

They encouraged patients to “ask their doctors about biosimilars,” a call that highlights a disconnect between perception and reality. For many therapeutic areas, 

; for others—particularly in oncology—biosimilars are so widely adopted that patients may already be receiving them without realizing it.

 As a result, the immediate public impact of this guidance is likely to be modest, even as it lays the groundwork for long-term gains in affordability and access.

If development efficiencies are not paired with improved commercial viability, many biologics will continue to struggle to gain market uptake, and potential cost savings will remain unrealized. Stakeholders must now look beyond regulatory reform to focus on aligning incentives, ensuring manufacturing capacity, and reinforcing provider and patient education to build lasting confidence in biosimilars.

Scientific considerations in demonstrating biosimilarity to a reference product: updated recommendations for assessing the need for comparative efficacy studies. FDA. October 29, 2025. Accessed October 29, 2025. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product-updated-recommendations

Niazi SK. BioRationality: the FDA sets sights on removing clinical efficacy studies for biosimilars. The Center for Biosimilars

. October 29, 2025. Accessed October 29, 2025. 

https://www.centerforbiosimilars.com/view/biorationality-the-fda-sets-sights-on-removing-clinical-efficacy-studies-for-biosimilars

Biosimilars reform. FDA. October 29, 2025. Accessed October 29, 2025. 

https://www.hhs.gov/live/live-1/index.html#12163 

Biosimilars Forum applauds FDA and Commissioner Dr. Marty Makary for supporting safe, effective and lower-cost biosimilars. The Biosimilars Forum. October 29, 2025. Accessed October 29, 2025. 

https://biosimilarsforum.org/2025/10/29/biosimilars-forum-applauds-fda-and-commissioner-dr-marty-makary-for-supporting-safe-effective-and-lower-cost-biosimilars/

Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars. February 5, 2025. Accessed October 29, 2025. 

Jeremias S. The age of adalimumab is upon us: how stakeholders can prepare. The Center for Biosimilars. June 28, 2023. Accessed October 29, 2025. 

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 October 29, 2025. 

Trump delaying triple-digit pharma tariffs to negotiate drug price deals. Politico. October 1, 2025. Accessed October 29, 2025. 

https://www.politico.com/news/2025/10/01/trump-delays-triple-digit-pharma-tariffs-to-negotiate-drug-price-deals-00590051

Santoro C. Biosimilar uptake lags in US despite potential cost savings. 

. August 16, 2024. Accessed October 29, 2025. 

https://www.ajmc.com/view/biosimilar-uptake-lags-in-us-despite-potential-cost-savings

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability.

A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development

The growing adoption of biosimilars for complex retinal diseases is heavily dependent on confirmation of the drug’s stability under realistic clinical handling conditions. A recent study, 

 provided critical data supporting the extended physicochemical and biological stability of XSB-001 (Ximluci; STADA Arzneimittel AG), a biosimilar referencing Lucentis (reference ranibizumab), which has been available in Europe since 2023.

A recent study confirms the stability of XSB-001 biosimilar for retinal diseases, ensuring quality during clinical handling and enhancing patient care efficiency. | Image credit: 61766578 - stock.adobe.com

Ranibizumab, an anti–vascular endothelial growth factor (VEGF)–A fragment, is a cornerstone treatment for serious retinal conditions, including neovascular age-related macular degeneration (nAMD) and diabetic macular edema. While XSB-001 previously demonstrated equivalent efficacy and safety to the reference product in clinical trials, the question of its stability following preparation for injection remained a key consideration for health care providers and payers.

Ophthalmic practices often draw up injectable medications into syringes days or weeks in advance for efficiency and logistical planning. This “in-use” preparation exposes the drug to variables like container materials, temperature fluctuations, and light. As such, researchers decided to conduct this study, which evaluated XSB-001 under real-world handling conditions for 30 days. They specifically sought to confirm that prefilled syringes stored long-term and subsequently exposed briefly to ambient temperature and light (simulating transportation and preparation time) would maintain their required quality specifications.

Key Data Points Confirming Extended Quality

The stability study examined XSB-001 stored in its original vials at 5±3°C and subsequently prepared into 2 different types of commonly used syringes. Samples were maintained for 30 days, with a critical subset then exposed to 48 hours of room temperature, humidity, and ambient room lighting to replicate actual clinical use prior to injection.

Across all test conditions and both syringe types, the biosimilar maintained all required physicochemical and biological criteria.

 Size exclusion–high-performance liquid chromatography (SE-HPLC) analysis confirmed high monomer purity, averaging 99.6%. This surpassed the required threshold of 99.0% or greater.

 Low molecular weight species were consistently observed to be below the detection limit (<0.35%), satisfying the requirement of 1.0% or less.

 Reverse-phase high-performance liquid chromatography (RP-HPLC) analysis showed consistent main peak purity of 97.3%, exceeding the 97.0% or higher criterion.

A recent study confirms the stability of XSB-001 biosimilar for retinal diseases under realistic clinical handling conditions.

Christina Mattina

FDA Approves Poherdy: First Interchangeable Biosimilar to Perjeta

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

Biosimilar Monthly Roundup: October 2025

A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development

Real-World Stability Confirmed for Biosimilar Ximluci in Prefilled Syringes

Review Identifies Gaps in Evidence on Biosimilar DMARD Use During Pregnancy

Global Biosimilars Market Sees Gains in Access and Pipeline Expansion

Biosimilar Tocilizumab Shows Cost-Effectiveness Advantage in Spanish RA Population

EC Approves New Biosimilars for Bone and Eye Conditions

Real-World Evidence Supports Biosimilar HLX02 in Metastatic Breast Cancer