In July, the U.S. Food and Drug Administration (FDA) announced its Biosimilars Action Plan. At the same time, FDA Commissioner Scott Gottlieb harshly criticized the pharmaceutical industry and its tactics in delaying biosimilar competition.
Yesterday, the agency and Gottlieb doubled-down on the Action Plan and added to it. The FDA released two new draft Q&A guidance documents on biosimilar development and two final guidance documents on the same topics, as well as a proposed amendment to the definition of a biological product.
Regulatory Focus notes, “The efforts are part of FDA’s decade-long work to begin, starting in March 2020, transitioning the approved marketing applications for a subset of biological products, such as insulin and human growth hormone—which were previously approved as drugs under section 505 of the FD&C Act—to be deemed to be biologics licenses.”
What this comes down to is specific biologics will be pulled from the FDA’s Orange Book on March 23, 2020 and placed into the Purple Book. All subsequent applicants that follow on won’t be able to depend on these New Drug Applications (NDAs) for approval but will have to follow a biosimilar pathway for approval.
Speaking at the CMS/FDA Summit in Washington, D.C. yesterday, Gottlieb indicated that the goal of the new policies and revised guidance were two-fold: to prevent companies from gaming the exclusivity provisions to fend off biosimilar entry into the market, and to ensure that when drugs transition into biologics, they don’t receive extra exclusivities they aren’t entitled to.
Gottlieb also said that the agency is issuing notice of how, if requested, it will review trial protocols submitted by biosimilar applicants to determine whether the protocols have comparable safety protections compared to those in the risk evaluation and mitigation strategy (REMS) for the reference drug they’re copycatting.
“If requested,” Gottlieb said, “the FDA will issue a letter to the reference product holder informing them that comparable protections exist, and that the FDA won’t consider it to be a violation of the branded drug company’s REMS to provide the biosimilar sponsor with a sufficient quantity of the reference product to perform testing necessary to support its biosimilar application.”
In his statements, Gottlieb noted, “There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible. Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients.”
Part of his talk was to strongly criticize the industry over the high price of insulin for what were essentially decades-old drugs. Part of the new guidance is designed to stimulate competition in the insulin market and bring down their costs. How this will be received by an industry that is already struggling with downward pressure on diabetes medications remains to be seen.
“We’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive,” Gottlieb stated. “These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.”
Three companies control 90 percent of the insulin market: Eli Lilly, Novo Nordisk and Sanofi Aventis. Although that relative lack of competition is partly behind the pricing, another part has to do with the way insulin products have been regulated.
By most definitions, insulins are biological drugs made from living cells. But they’re not regulated the way biologics are, nor are copycat or generic versions, the so-called “follow-on insulins,” or, in other words, biosimilars. But that will change in 2020 when insulins will be regulated as biologics.
