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The BPCIAs 351(k) pathway created two approval tiers: the biosimilar standard and the higher interchangeable standard

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They begin by selecting well-documented investigational materials, reviewing analytical data, understanding proper laboratory handling, and maintaining rigorous scientific procedures throughout the research process

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doi: 10.1016/j.jacc.2017.11.024 [DOI] [PubMed] [Google Scholar] 108.Volpe CMO, Villar-Delfino PH, Dos Anjos PMF, Nogueira-Machado JA

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