OR WAIT null SECS
While FDA dithers on regulatory guidance, state efforts to anticipate biosimilar regulation are mostly being rejected
Biotechnology is very important to California, home of Amgen and Roche’s Genentech, arguably the two biggest biotech firms in the world. So it’s with some bravery—for a politician—that Governor Jerry Brown vetoed a bill passed resoundingly by California’s legislature, SB 598, that would require pharmacies (read: “pharmacy benefit managers”) to notify patients’ physicians of the type of biosimilar drug being used. On the hypothesis that there will be multiple versions of biosimilars for one branded biologic, the proposed rule would require pharmacies to track which biosimilar was used on which patient.
Amgen and Genentech, along with the BIO trade association and PhRMA, among others, have been advocating this measure in many state legislatures. But wherever they have gone, the Generic Pharmaceutical Assn. (GPhA) has followed, with its president, Ralph Neas, countering that the bill “would erect substitution barriers, implements an unnecessary pharmacy practice, and would create doubt about the safety and effectiveness of more affordable interchangeable biosimilars.” In his rejection letter to the California legislature, Gov. Brown seems to avoid dealing with these complexities, saying simply that “This requirement, which on its face looks reasonable, is for some reason highly controversial.” It’s certainly probable, though, that he was also paying attention to state insurance groups such as CalPERS, who have noted that the notification requirement could prevent fuller biosimilar substitution, thus keeping biologic drug costs elevated.
Similar legislation has been proposed in at least 10 state legislatures, but for the most part has been rejected or severely limited, GPhA notes.
There’s no little conceit to the industry effort: Even while FDA is trying to work out its regulatory process for biosimilar approvals, this effort would keep biosimilars separate from the branded biologics. In other contexts (notably the years-long effort to get national track-and-trace legislation passed), PhRMA and Amgen—both members of the Pharmaceutical Distribution Security Alliance—have argued for the value of a single national standard. Language in the Affordable Care Act created the framework for biosimilar interchangeability, and FDA issued its preliminary guidance in 2012 following that framework. The California decision, though, will certainly not be the final word on the topic.