A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more
8/13/2020
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Biosimilars ,
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Food and Drug Administration (FDA) ,
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The Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010 to provide an abbreviated regulatory pathway for biosimilars. One of the BPCIA’s key features is a patent dispute resolution process known as the...more