Biosimilar 'Patent Dance,' Litigation Could Coincide With Possible Approval

FDA's recent acceptance of the first publicly announced biosimilar application sets into motion a series of exchanges between the innovator and biosimilar companies on patents -- the first time this statutorily outlined process will be tested, although companies previously have sought to head off market access issues with declaratory judgments. The IP issues will play out alongside a host of other biosimilar regulatory issues and could lead to a lawsuit around the time FDA is scheduled to complete its review...