Where BPCIA Issues Stand As FDA Approves 25th Biosimilar

Law360 (November 27, 2019, 3:43 PM EST) -- On Nov. 15, the U.S. Food and Drug Administration approved Pfizer Inc.’s adalimumab product, a biosimilar to AbbVie Inc.'s Humira, marking the 25th approval of a biosimilar under the Biologics Price Competition and Innovation Act.

A biosimilar is a product that is highly similar to a branded reference biologic product “notwithstanding minor differences in clinically inactive components” and that exhibits “no clinically meaningful differences” as compared to the branded product in terms of “safety, purity, and potency.”[1]

The road to the 25th approval has been long and has involved some of the biggest companies and medications in the pharmaceutical industry. In...

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