FDA Pushes Faster, Cheaper Route for Biosimilar Approval
October 29, 2025
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2 min
7 Key Takeaways
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1
Biologics account for 5% of prescriptions but over half of drug spending.
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2
FDA aims to accelerate biosimilar access through new guidance.
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3
The guidance focuses on simplifying biosimilarity assessments.
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4
Current market share of biosimilars is less than 20%.
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5
FDA has authorized 76 biosimilar products since 201
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6
Comparative efficacy studies are costly and their necessity is minimized by the new guidance.
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7
Initiative aligns with the Biologics Price Competition and Innovation Act of 20
The FDA has released new draft guidance to streamline the development of biosimilars, aiming to reduce costs and enhance access to lower-priced biologic therapies. Acknowledging that biosimilars, despite being therapeutically equivalent to branded biologics, represent less than 20% of the market, the FDA aims to simplify biosimilarity assessments by minimizing unnecessary clinical trials. This initiative, aligning with the Biologics Price Competition and Innovation Act of 2010, is expected to expedite the entry of quality biosimilars into the US market.
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