A milestone in facilitating the development of biosimilars

By: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research and Hilary Marston, MD, MPH, Medical Director

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created a pathway for the US Food and Drug Administration to approve biosimilars. A biosimilar is a biologic (biological) product that is very similar to an existing FDA-approved biologic product (also called the reference product) and has no clinically significant differences from it. Biologics are some of the most expensive treatments in the United States, and approval of biosimilars can improve competition, reduce costs for health care systems, and increase patient access to biologic therapies.

This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilars, products that treat a wide range of chronic and serious diseases and have already had a significant impact on patient access. Biosimilars are already approved for 15 different reference biologics and treat diseases such as rheumatoid arthritis, inflammatory bowel disease, some cancers, psoriasis, diabetes, macular degeneration, osteoporosis and more.

According to a 2023 report from the Accessible Medicines Association, FDA-approved biosimilars have saved the healthcare system $23.6 billion since the first biosimilar product was approved in 2015. Collectively, patients have used biosimilars for almost 700 million days of therapy, 344 million. days when patients received care they would not have received otherwise. The impact and potential of biosimilars is significant not only in terms of savings to the healthcare system, but also for healthcare equity and to help improve patient access to medicines that were previously out of reach .

A lot has gone on behind the scenes to reach this milestone, and public health benefits have been the FDA’s guide. Agency staff have worked to implement the biosimilar pathway by developing the necessary guidance that provides clarity and transparency to stakeholders and to keep pace with advances in science and technology that support the development of biologics. Each approved biosimilar represents hundreds of hours of review, along with facility inspections of the work that biosimilar manufacturers do to ensure that their testing and facilities meet the FDA’s high approval standards.

The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan (BAP), first published in 2018. The action plan is a framework to support the innovation and competition of biological products. It contains four strategies:

• Improve the efficiency of the process of development and approval of biosimilar products.
• Maximize scientific and regulatory clarity for the biosimilar product development community.
• Develop effective communications to improve understanding of biosimilars.
• Support market competition by reducing attempts to unfairly delay competition.

The progress and goals the agency has achieved in these areas are described in a recently released summary report of these activities. This summary serves as a progress report of FDA’s accomplishments and highlights biosimilar development activities conducted in collaboration with various agency offices.

These strategies remain relevant as the biosimilars market continues to grow. Accordingly, we are updating and republishing our Biosimilars Action Plan to reinforce our commitment to these important initiatives and to articulate our strategy to further expand the availability and use of biosimilars.

The BAP is now web-based and can be easily updated with completed deliveries in real-time. The updated action plan still contains four strategies similar to those articulated in the 2018 version. Within each goal, we have identified specific goals and outcomes that will promote the development, communication, clarity, and adoption of biosimilars.

The FDA is committed to the continued development and approval of high-quality, safe and effective biosimilars that can provide increased access to patients in need of biologic treatments. We celebrate the first 50 biosimilars approved by the FDA, recognize the tremendous work that has gone into reaching this milestone, and look forward to the next 50 biosimilar approvals, benefiting patients across the country.

For more information, visit:
FDA Biosimilars Website
FDA Biosimilars Consumer Update
Biosimilars Spotlight from CDER Science