With legislation requiring pharmacists to notify prescribing physicians that they have filled a prescription with an FDA-approved biosimilar now ready for California Gov. Jerry Brown’s (D) approval, the U.S. Food and Drug Administration (FDA) has apparently expressed concern with such state legislation. In a statement released just a few days before the California Senate agreed overwhelmingly to approve the Assembly’s S.B. 598 amendments, an FDA spokesperson reportedly said, “Efforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower-cost treatments.” FDA further noted, “Congress deliberately set a very high bar for a biosimilar product approval.” Details about the California bill appear in Issue 63 of this Bulletin.
Similar bills are pending before a number of state legislatures; a few have been enacted, despite the federal government’s failure to approve any biosimilars to date or to finalize a pathway for regulatory approval. According to a press report, the flurry of legislative activity followed lobbying by the companies that make the biologics for which biosimilars would be substituted. Meanwhile, the Generic Pharmaceutical Association (GPhA) issued a statement about the passage of S.B. 598, claiming that it “would create unnecessary barriers between Californians and newer, lower-cost versions of biologic therapies, known as biosimilars, particularly interchangeable biosimilars.” The organization called on the governor to veto the bill. See BioPharma-Reporter.com, August 28, 2013; Law360, August 29, 2013; GPhA News Release, September 4, 2013; Los Angeles Times, September 5, 2013.