Report: A Decade of Biosimilars and Barriers Remain

Wednesday March 5, 2025

Matrix Global Advisors report highlights current barriers and recommendations for robust competition and patient savings in the next decade

WASHINGTON — The Biosimilars Council today commented on a report released by Matrix Global Advisors, US Biosimilars Market: Addressing Barriers to Success in the Second Decade, which recommends several policy and regulatory steps that would accelerate biosimilar competition and patient savings in their second decade of use.

“Today’s report highlights the immense opportunity and challenges facing biosimilar competition,” said Craig Burton, Executive Director of the Biosimilars Council. “Biosimilars provide lower prices and expand patient access to care, but policy and market barriers continue to stymie biosimilar competition. Policymakers must ensure a robust and sustainable biosimilar market by streamlining the FDA approval pathway, removing the unnecessary and confusing interchangeability designation, ensuring PBM coverage of new biosimilars, and reforming Medicare reimbursement policy for biosimilars.”

Since March 2015, the FDA has approved 63 biosimilars and 42 have launched so far. The report from Matrix Global Advisors, authored by Alex Brill and Christy Robinson, outlines several recommendations to ensure a robust biosimilars competitive marketplace and patient savings.

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About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

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February 3–5, 2024 | Amelia Island, MD

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