FDA Law Blog: Biosimilars

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. The plain text of 35 U.S.C.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

Safe Biologics

NOVEMBER 12, 2023

6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.

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European Pharmaceutical Review

JANUARY 18, 2024

The dominance of the US within the 7MM is due to its larger insomnia population and higher drug prices. GlobalData considered drug pricing and market exclusivity to be two major obstacles. Furthermore, during the forecast period, Hetlioz, SM-1, and sunobinop are forecast to launch in the US only,” Wong explained.

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pharmaphorum

FEBRUARY 18, 2021

Drug prices to plummet in wave of expiring patents”. Price decay after loss of brand exclusivity”. These are just three headlines that come up when you Google “drug patent expiry”. Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. “Patent losses could sink Allergan”.

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