FDA Is Not Playing Games with Biosimilars

While many people headed to summer vacation fun, FDA was busy in July, including a reorganization plan, new guidance documents for gene therapy development, efforts to prevent drug shortages, and more flexible import policies.

FDA’s Biosimilars Action Plan (1), announced on July 18, 2018, may have the most implications for the market segment. In introducing the plan, FDA Commissioner Scott Gottlieb took innovator biopharmaceutical companies to task for impeding the delivery of biosimilar drugs to market (2). To date, only three of the 11 biosimilar drugs approved by FDA have reached patients, and the lack of competition in the biosimilar space cost US patients more than $4.5 billion in 2017, Gottlieb noted.

“Sometimes it feels as if we’re seeing the biosimilars version of ‘Groundhog Day,’ with brand drug makers replaying many of the same tactics, and all of us being too susceptible to many of the same misconceptions about biosimilars’ safety and efficacy relative to originator biologics,” Gottlieb said in prepared remarks at the Brookings Institution. “We’re falling into some of the same doubts and policy constraints that were used to deter competition from generics in the years after the Hatch Waxman Act. But we’re not going to play regulatory whack-a-mole with companies trying to unfairly delay or derail the entry of biosimilar competitors. We’re not going to wait a decade or more for robust biosimilar competition to emerge.”

Delaying tactics may discourage biosimilar sponsors from developing products and reduce public confidence in market-based pricing mechanisms, ultimately hurting innovator companies, Gottlieb said; therefore, FDA’s Biosimilars Action Plan seeks to achieve a balance between innovation and competition. The Plan, part of the Trump Administration’s Blueprint to Lower Drug Prices, focuses on improving the efficiency of the biosimilar and interchangeable product development and approval process; maximizing scientific and regulatory clarity for biosimilar product development; improving understanding of biosimilars among patients, clinicians, and payors; and supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.

“Effective market competition from biosimilars depends on additional actions from our public and private sector partners to align reimbursement and formulary design to encourage appropriate biosimilar adoption,” Gottlieb said. “Competition requires all of us to shine a light on the anti-competitive impact of tying rebates and bundling biologics with other products to protect biologics’ market share. And it requires us to educate providers and patients about biosimilars, and why people should have confidence in the safety and effectiveness of these FDA-approved products,” he said.

Prior to the introduction of the Biosimilar Action Plan, the Biotechnology Innovation Organization said-in response to the Blueprint to Lower Drug Prices-that it was working to “increase marketplace competition by speeding regulatory approval of more innovative drugs, and promoting greater and faster generic and biosimilar entry once patents and exclusivities for innovator drugs have expired,” but opposed ideas that “impeded innovation” such as price controls, drug importation, or direct government of negotiation of Medicare drug prices (3).

While there appears to be general agreement on the end-game, the means of getting there are up for debate. A public hearing scheduled for Sept. 4, 2018 could have some interesting conversations.

References

1. FDA, Biosimilars Action Plan: Balancing Innovation and Competition, July 2018.
2. FDA, Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan, July 18, 2018.
3. Biotechnology Innovation Organization, “BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs,” Statement, July 13, 2018.

Article Details

BioPharm International
Vol. 31, No. 8
August 2018
Page: 6

Citation

When referring to this article, please cite it as R. Peters, " FDA Is Not Playing Games with Biosimilars" BioPharm International 31 (8) 2018.