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# Biosimilar Approvals Will Increase: FDAer
- URL: https://www.fdaweb.com/biosimilar-approvals-will-increase-fdaer/
- Published: 2018-04-18T12:00:00.000Z
- Updated: 2026-09-14T23:59:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141255

Speaking 4/17 at the National Policy and Advocacy Summit on Biologics and Biosimilars, CDER Office of New Drugs associate director **Leah Christl** said that over time the U.S. will see a dramatic increase in the number of biosimilar approvals, based on the quantity of applications that the agency is currently receiving. The Center for Biosimilars [reports](FDA's%20Leah%20Christl%20Provides%20an%20Agency%20Perspective%20on%20the%20Biosimilars%20Landscape) that Christl said that when FDA started on the biologics pathway eight years ago when the Biologics Price Competition and Innovation Act was implemented, it expected that biosimilar approval and uptake would proceed the way it had in Europe.

“We came in to having this approval pathway later than other areas of the world, and the expectation was that we would have companies bring to us the products that they had approved in other areas would just seek approval here,” Christl said. “But we didn’t see that. What we saw was the global development programs were ongoing, and they were bringing monoclonal antibodies.”

Currently, she said, the U.S. is seeing the same applications as Europe is seeing and there is a robust pipeline in regard to the applications being submitted for approval.