Blockbuster Biologics Review Issue 14

Morgan Lewis
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Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), 31 biosimilars have been approved, 16 of which have launched. Strikingly, the number of post-grant challenges against biologics patents has precipitously dropped since reaching a peak in 2017. On the legislative front, the Senate introduced a bill which would prohibit biological product manufacturers from compensating biosimilar companies in exchange for the biosimilar company delaying entry into the market.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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