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Q&A with ICON’s Centre for Biosimilar Drug Development

Recently we sat down with two SMEs from ICON’s Centre for Biosimilar Drug Development and posed three questions that we are hearing are on the minds of biosimilar drug developers, regulatory authorities, HCPs and payers.

Q. How are recent changes to biosimilar regulations reshaping the competitive landscape for branded biologics and what should manufacturers be doing now to prepare?

A. Recent FDA and EMA biosimilar regulatory updates are accelerating competition for branded biologics by streamlining development pathways. Greater reliance on analytical comparability data, reduced clinical trial requirements and the removal of many interchangeability study expectations are lowering development costs and shortening timelines for biosimilar manufacturers. 

For originator companies, the implications are significant: faster biosimilar market entry, increased pricing pressure and reduced opportunity to preserve market share after patent expiry. As biosimilars face fewer regulatory barriers, competition is shifting from obtaining approval to demonstrating value in the marketplace. 

However, regulatory acceptance does not automatically translate into clinician adoption. The reduced emphasis on clinical efficacy studies may leave some healthcare providers hesitant to initiate or switch treatment, particularly for patients with serious or life-threatening diseases who are stable on an established biologic. This creates an opportunity for branded manufacturers to differentiate through continued evidence generation and by demonstrating long-term safety, effectiveness and real-world value.

To remain competitive, originator manufacturers should act now on several fronts. Lifecycle management strategies, including new formulations, delivery devices and expanded indications, can help sustain product differentiation. Companies should also strengthen engagement with providers, payers and patients through education, access programs and support services that enhance the overall treatment experience. 

Finally, manufacturers should proactively assess portfolio vulnerabilities and invest in next-generation biologics and combination products. Success in an increasingly biosimilar-driven market will depend less on regulatory exclusivity and more on innovation, evidence generation, patient support and effective market access strategies.

 

Q. How will the changing biosimilar landscape affect relationships with HCPs, patients and payers?

A. As biosimilar adoption grows, stakeholder conversations are shifting from demonstrating similarity to building confidence in acceptance. The future of biosimilars will largely depend on the needs of healthcare providers (HCPs), patients and payers and supported by real-world evidence, access and confidence across stakeholders. 

For HCPs, growing real-world evidence will support prescribing and patient discussions. However, changing regulations that could potentially eliminate or reduce the need for clinical efficacy studies, limiting clinical data for reference, could create an increased need for post-approval evidence.  As multiple biosimilar options become available for the same reference product, providers must balance clinical evidence, payer requirements, formulary preferences and patient needs and confidence in treatment switching when making decisions. What was previously a decision made by HCPs is becoming a shared decision among providers, patients and payers.

For patients, broader access to biosimilars can make treatment options more affordable and expand insurance coverage. Continued education from HCPs will be crucial to addressing misconceptions, supporting decision-making and reinforcing confidence in equivalent clinical outcomes compared with reference products. Ensuring patients are informed and feel comfortable with treatment transitions will become increasingly important. 

From a payer perspective, biosimilars increase market competition, improve patient access and establish opportunities for cost savings while maintaining standards for safety and efficacy. As a result, payers may encourage biosimilar use through formulary preferences and treatment pathways.  Future discussions will focus on overall value, treatment continuity and patient access. 

Ultimately, the future of biosimilars will be shaped not only by regulatory approvals, but by investing in stakeholder interests, real-world evidence and patient-centred services.  With the biosimilar competition growing, those organisations that successfully align the needs of HCPs, patients and payers and demonstrate value and confidence in treatment switching will maximise the impact biosimilars have moving forward. 

 

Q. How might new biosimilar policies influence innovation and investment in biologic therapies?

A. A key challenge for both regulators and industry alike is balancing competition with encouraging and rewarding continued innovation. Both are needed to have healthy, robust biologic treatment options for patients and providers. Recent changes in biosimilar development guidelines will accelerate competition, but not at the expense of innovation; in fact, they may encourage it. 

For biopharmaceutical manufacturers of branded products to remain competitive in the marketplace, they will need to shift their main strategy from product lifecycle extensions of and market exclusivity of existing approved biologics, to using research funds for new treatments that address unmet medical needs, offer meaningful clinical differentiation, measurable improvements in patient outcomes and quality of life and healthcare value. These biologics could include next-generation molecules such as antibody-drug conjugates (ADCs), bispecific antibodies (BsAbs) that simultaneously bind to two different antigens or eptiopes at once, novel combination therapies, new targets and precision medicine. 

At the same time, increased approval and adoption of biosimilars globally will expand patient access to treatment, but at a lower cost. These healthcare savings can then be utilised to fund research and development of these newer and more innovative therapies to support continued advancement and expand the overall biologics landscape. 

Ultimately, the impact of new biosimilar policies is unlikely to be a reduction in innovation. Rather, they are expected to redirect investment toward therapies that offer meaningful advances in patient outcomes, creating a more dynamic and sustainable ecosystem for biologic drug development.

Contributors

Kim Salgado

Head of Centre for Biosimilar Drug Development

Lauren Zalin

Clinical Program Manager

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