George O'Brien

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Latest Posts › Biosimilars

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Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. ...more

4/27/2021 / Biosimilars , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , New Legislation , Pharmaceutical Industry , Prescription Drugs , Product Exclusivity , Regulatory Reform

Four new FDA guidances and proposed rule advance biosimilars policy framework

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

12/12/2018 / Biologics Price Competition and Innovation Act of 2009 , Biosimilars , Food and Drug Administration (FDA) , Healthcare , Life Sciences , New Guidance , Proposed Rules , Regulatory Agenda , Research and Development , Rulemaking Process

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives...more

8/10/2018 / Biologics , Biosimilars , Competition , Food and Drug Administration (FDA) , Hatch-Waxman , Pharmaceutical Industry , Prescription Drugs , Product Labels , Regulatory Oversight , Regulatory Requirements

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