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BioWorld - Thursday, July 23, 2026
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Home » CDER approval numbers show biosimilar advance, steady pace of novel BLAs
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CDER approval numbers show biosimilar advance, steady pace of novel BLAs

Jan. 7, 2020
By Mari Serebrov
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
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