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The Association for Accessible Medicines (AAM) report highlighted “excessive webs of secondary patents” as a major obstacle to biosimilar access, proposing three legislative solutions to boost access. Global momentum in biosimilar regulatory advancements was seen with key approvals in the U.S., Europe, and Canada, enhancing access to affordable therapeutic options. However, knowledge gaps among consumers and health care professionals were identified, revealing significant uncertainties and suboptimal understanding of biosimilar information, emphasizing the need for clearer, comprehensive educational initiatives.
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July 2025: A Month of Transitions and Progress in the Biosimilar Industry
The biosimilar sector experienced significant progress throughout July 2025, marked by noteworthy regulatory approvals, legislative proposals to address market access barriers, and a continued need for enhanced public and professional understanding. Here is a compact overview of July’s key developments in the biosimilar industry.
Steps Towards Amplifying Biosimilar Accessibility: Tackling Patent Thickets
The Association for Accessible Medicines (AAM) has released a new report flagging patent thickets as a significant barrier to biosimilar access. It explained that these “excessive webs of secondary patents” are created by branded manufacturers to extend market exclusivity, thereby inflating costs and delaying affordable treatment.1 The US litigation process involves an overwhelming number of asserted patents (11 to 65 per product), a number significantly higher than other countries.
To address this, the AAM report suggested three legislative solutions: setting a limit on the number of asserted patents in biologic patent litigation, enabling biosimilar manufacturers to settle litigation in a way that promotes competition, and instituting a statutory safe harbor for patented methods of treating diseases. These steps are expected to abbreviate litigation delays, curb patent abuse, and encourage timely market entry while reducing health care costs and improving patient access.
New Global Biosimilar Approvals Broaden Treatment Choices
There have been significant regulatory advancements in the biosimilar sector worldwide, as demonstrated by new approvals and positive opinions in the US, Europe, and Canada.2 The FDA has accepted the biologics license application (BLA) for BAT2506, a proposed biosimilar to Simponi, aimed at treating various autoimmune conditions.
In Europe, the EMA issued a positive opinion for Eyluxvi (ALT-L9), a biosimilar to Eylea, for the treatment of ophthalmic conditions such as wet age-related macular degeneration. Also, the European Commission approved Denbrayce and Izamby, denosumab biosimilars referencing Xgeva and Prolia, for bone-related conditions and osteoporosis.
Canada granted approvals for Aflivu and Yesafili, both biosimilars to Eylea, promising increased access to affordable, high-quality treatment options.
Biosimilar Market Void: A White Paper Proposes Solutions
In response to a previous report warning of a potential “biosimilar void,” where 90% of biologics losing exclusivity in the next decade lack biosimilars in development, a new white paper from Samsung Bioepis suggests urgent policy reforms to ensure market sustainability.3 These reforms include:
- Introducing free pricing at launch for biosimilars.
- Implementing multi-winner tenders to diversify supply.
- Linking biosimilar pricing to comprehensive health technology assessments.
- Establishing minimum price boundaries to prevent excessive price erosion.
- Promoting collaborative frameworks across Europe for harmonized policies. The paper also emphasizes the need for targeted education to build confidence in biosimilars among prescribers and patients.
Potential Impact of Medicare Price Negotiations on the Biosimilar Market
According to a report from Matrix Global Advisors, government price negotiations as part of the Inflation Reduction Act may unintentionally impede biosimilar development and widen the “biosimilar void.”4 While the IRA aims to control high drug costs, the prospect of such negotiations could discourage manufacturers from launching biosimilars, particularly for high-sales biologics. This could risk billions in potential annual savings if biosimilar entry is delayed. Instead of suppressing biosimilar entry through government pricing, the report suggests addressing anticompetitive behaviors like patent thickets and encouraging market competition.
A Major Step Forward for Insulin Biosimilars in a Growing Market
The FDA approved Kirsty (insulin aspart-xjhz) as the first rapid-acting interchangeable biosimilar product to Novolog (insulin aspart), marking an important stride towards making insulin more affordable for millions of Americans with diabetes.5 Designated as “interchangeable,” Kirsty can be substituted for Novolog at the pharmacy without requiring a new prescription in states where laws permit, thereby improving patient access and intensifying competition. This follows the approval of Merilog (insulin-aspart-szjj), the first insulin aspart biosimilar, and two other insulin glargine products.
Meanwhile, a recent narrative review addressed ongoing concerns among healthcare providers and patients about the efficacy, safety, and quality of biosimilar insulins in comparison to reference products.6 The review analyzed regulatory pathways in the European Union and the US, and reconfirmed the safety and efficacy of insulin biosimilars. The researchers highlighted the need for comparative analytical, functional, preclinical, and pivotal clinical pharmacology studies for approval.
Addressing Biosimilar Knowledge Deficiencies
Despite the increasing presence of biosimilars, a recent study revealed significant knowledge deficits and uncertainties among consumers and healthcare professionals (HCPs).7 Using mock advertisements for a fictional biosimilar, the study found that understanding of biosimilar information was less than optimal, with only 48.5% to 62.0% of consumers and 68.4% to 88.4% of HCPs correctly understanding key characteristics such as comparable safety and efficacy.
Expanded definitions were found to lead to more positive attitudes and stronger prescribing intentions among HCPs. Both groups showed a preference for more detailed definitions, highlighting the urgent need for improved, comprehensive educational initiatives. Better understanding and adoption of biosimilars is critical to realizing their cost-saving benefits and improving access to treatment.
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