Focus on biosimilars yields record FDA approvals in 2024

10 January 2025

The US Food and Drug Administration approved 50 novel drugs in 2024, continuing to outpace its global regulatory peers.

The agency also achieved a record-breaking milestone with the approval of 18 biosimilars, including eight targeting reference products that previously had no biosimilar competition.

Several were also approved as interchangeable, meaning they can be substituted for the reference product at the pharmacy level without prescriber involvement, subject to state law.

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