By two-to-one, GEN readers aren’t satisfied with the status quo surrounding bringing biosimilars to the U.S. drug market. When asked how satisfied they were with progress toward bringing biosimilars to the U.S. market, 62.7% said “not much.” The top two answers racked up under one-third of the vote, with 13.7% saying they were “somewhat” satisfied and 15.7% saying they were “very” satisfied. The remaining 7.8% were undecided.
The poll began soliciting responses February 6; three days later the FDA released its long-awaited draft guidance on a pathway for developing and approving biosimilars, using a risk-based “totality-of-the-evidence” approach. The EMA has slowly but surely developed guidelines for different types of biosimilars; most recently, it began soliciting formal comment last month on interferon beta biosimilars. There are two interferon beta-1a drugs—Biogen Idec’s Avonex and Merck Serono’s Rebif—and two interferon beta-1b drugs—Betaseron made by Bayer HealthCare and Novartis’ Extavia, a copy of Betaseron that Novartis pays Bayer royalties to market.