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 By comparison, the European Medicines Agency (EMA) has approved 31 biosimilar products (3) and refused or withdrawn about five.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…
