Pennsylvania Moves Closer To Adopting Biosimilar Legislation

Biotechs fighting to thwart biosimilar substitution have just moved closer to achieving their goal in one big state. A Pennsylvania senate committee has approved a bill that would make it harder for pharmacists to substitute biosimilars that the FDA has approved as interchangeable with a biologic. The bill, which would require physician notification, now goes to the full senate for a vote (here is the bill). The committee vote is only an interim step, of course, but if the legislation becomes law, it would be a significant victory for Amgen (AMGN) and Genentech, which have been lobbying more than a dozen states in hopes of preventing rivals from having easy entre to their lucrative markets.  Many biologics are priced at tens of thousands of dollars a year and once biosimilars become available, the debate over cost is expected to accelerate. As noted previously, the multi-state campaign promotes bills that would require a biosimilar must have been deemed by the FDA to be interchangeable with the prescribed medicine for the specified indicated use, even though the FDA has not yet approved a biosimilar or decided whether a biosimilar is interchangeable with a brand-name biologic. “We welcome the Pennsylvania Senate Public Health & Welfare Committee’s unanimous vote to report SB 405 favorably out of committee," an Amgen wrote in a statement. "As a producer of both innovative biologics and biosimilars, Amgen believes that SB 405 will help to instill confidence in the uti...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs