FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

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In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

In introducing FDA’s Biosimilars Action Plan (1) on July 18, 2018 at the Brookings Institution, FDA Commissioner Scott Gottlieb issued strong criticism of the biopharmaceutical industry’s slow delivery of biosimilar drugs to market.

Through July 2018, 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 in prepared remarks (2). The estimate was a preview of soon-to-be-released FDA analysis of biosimilar competition across Organization for Economic Co-operation and Development (OECD) markets and projections of the impact on the US market if all FDA-approved biosimilars were “successfully marketed here in a timely fashion,” Gottlieb said.

Biologic-based drugs represent 40% of total spending on prescription drugs, but less than 2% of Americans use them, said Gottlieb. “So, enabling a path to competition for biologics from biosimilars is key to reducing costs and to facilitating more innovation.”

Litigation, intellectual property, and pricing and rebate strategies have contributed to delays in getting biosimilars to market, similar to tactics employed with the rise of generic small-molecule drugs.

“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. “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.”

Competition strengthens innovator drug efforts

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. “Our aim is to reduce the time, uncertainty, and cost of drug development, while also supporting a competitive market through the efficient approval of lower-cost generic, biosimilar, and interchangeable alternatives after the expiration of patents or other statutory exclusivities,” Gottlieb noted.


FDA’s Biosimilars Action Plan, part of the Trump Administration’s Blueprint to Lower Drug Prices, focuses on the following four areas:

  • Improving the efficiency of the biosimilar and interchangeable product development and approval process. Priorities include development of application review templates for 351(k) biologics license applications; improved coordination and support within FDA through the Office of Therapeutic Biologics and Biosimilars; coordination with the Center for Drug Evaluation and Research; and introduction of information resources and tools to assist biosimilar sponsors, such as an index of critical quality attributes.

  • Maximizing scientific and regulatory clarity for the biosimilar product development community. Priorities include guidance documents for scientific and regulatory predictability, harmonization with international regulations, acceptance of non-US comparator products, and use of real-world data to support regulatory decisions related to biosimilars. To date, FDA has issued six final and four draft guidance documents for biosimilars.

  • Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors. FDA noted the need for audience-appropriate educational materials for patients, clinicians, and payors to inform various groups about biosimilars and the processes FDA uses to evaluate them.

  • Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition. FDA said it will clarify its position on issues affecting reference product exclusivity to achieve balance between innovation and competition. The agency also would identify ways statutory or regulatory requirements may delay biosimilar approvals and work with Congress to close any loopholes.

Evolving reform and acceptance

Gottlieb noted that the current generic-drug market “while not perfect, is robust in most respects. But it took about two decades to develop.” Prescriber and patient confidence in generic drugs had to be developed, legal tactics restricting competition had to be addressed, and coverage systems had to be changed to take advantage of generic entry, he said, and the experience with generic drugs demonstrates that FDA cannot address these issues alone.

“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.

“Without those actions, our collective vision of a pathway for more affordable biosimilar products will be frustrated,” he said.


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.