|Since the 2009 enactment of the Biologics Price Competition and Innovation Act (BPCIA) (1), the US Food and Drug Administration (FDA) has licensed six biosimilar products under PHS 351(k) and approved one product under FD&C 505 (b)(2). It also provided complete response letters (CRLs) to four biologics license application (BLA) filings (Table 1) (2). By comparison, the European Medicines Agency (EMA) has approved 31 biosimilar products (3) and refused or withdrawn about five.
There is no doubt that US market entry of biosimilars remains a slow process. Based on my first-hand experience in developing biosimilars for market and teaching about biosimilars over several years, I address herein the most critical questions about the fate of such products in the United States:
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