Biosimilar Developers Can Breathe a Sigh of Relief


With this morning’s Supreme Court affirmance of the bulk of the Affordable Care Act, the specter that the BPCIA framework for biosimilar introduction could be dismantled is no longer a concern.  Presumably it will be full speed ahead through the regulatory process, and we will see biosimilar applications for approval and attendant patent litigation before too long.  It will be years, though, before there will be sufficient experience to assess whether the BPCIA will achieve its goals of spurring competition for important biologics without undermining the incentives for new innovations.  In the meantime, one wonders whether there will be appetite among the stakeholders for preemptively amending the Act (for example, by changing the 12 year exclusivity period) when the firestorm over changing or repealing the ACA begins in the next Congress.