FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

01 August 2018

Rita C. Peters / BioPharm International

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:

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.


Previous publication Next publication

Media Center

  • 31 October 2018

    Scientists unveiled a more effective approach for assessing drug response

    Scientists from Eli Lilly and Company, the Icahn School of Medicine at Mount Sinai (New York, USA) and Sema4 (Stamford, USA) released results from a proof-of-concept study demonstrating that patient-derived cells offer a more effective approach for assessing drug response than conventional methods.

  • 30 October 2018

    Researchers developed an AI approach to identify antibiotic resistance genes

    Researchers at the University of California San Diego (USA) have developed an approach that uses machine learning to identify and predict which genes make infectious bacteria resistant to antibiotics. The approach was tested on strains of Mycobacterium tuberculosis – the bacteria that cause tuberculosis (TB) in humans. It identified 33 known and 24 new antibiotic resistance genes in these bacteria.

  • 29 October 2018

    Expanding the reach of gene editing with a new CRISPR enzyme

    The CRISPR-Cas9 gene editing system has been widely studied because of its potential therapeutic applications, but limitations in the number of locations on the genome it can target remain a major drawback. Now scientists at the Massachusetts Institute of Technology have identified a new Cas9 enzyme that they say can help CRISPR reach more gene mutations.

  • 26 October 2018

    Biotech Backed by Bain, Pfizer loads prime CNS assets into new biotech

    Pfizer has followed through on its pledge to divest a hunk of its neuroscience R&D, spinning several programs into a new company called Cerevel Therapeutics backed by $350 million in venture funding. Pfizer is contributing a trio of clinical-stage drug candidates—including a Parkinson’s therapy due to start phase 3 testing next year—plus a clutch of earlier-stage programs, while Bain Capital and affiliates stumped up the initial funding.

Read more