Search results for US

US prescribers’ attitudes and perceptions about biosimilars

Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Introduction: In the United States (US), a legal framework for approving biosimilars was established via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). At the time of writing (September 2022), 38 biosimilars have been approved […]

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A white paper: US biosimilars market on pace with Europe

Abstract: In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed. Submitted: 12 October 2020; Revised: 28 October 2020; Accepted: […]

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