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Biosimilar Regulatory Roundup: March 2020


During March, the FDA worked to mitigate drug quality issues potentially arising from the coronavirus disease 2019 (COVID-19) pandemic, established a new regulatory pathway for certain biologics, and launched a high-profile effort with the Federal Trade Commission to halt anticompetitive practices.

Between the response necessitated by coronavirus disease 2019 (COVID-19) and a regulatory change for approving biological products, March was an eventful month for the FDA.

The month kicked off with a workshop in which members of the FDA and Federal Trade Commission (FTC) addressed anticompetitive practices that hinder biosimilar uptake. The agencies discussed their concerns about these practices and how they are responding.

FDA Commissioner Stephen M. Hahn, MD, emphasized that the purpose of the workshop was to generate public confidence in regulators’ commitment to creating a healthy biosimilars marketplace.

Additionally, CMS launched a model that would cap insulin co-pays under Medicare Part D at $35. Under this model, insulin users who are enrolled in participating plans are expected to save an average $446 in annual out-of-pocket costs for insulin—a decrease of over 66%—and the federal government is expected to save more than $250 million over the next 5 years, thanks to coverage gap discounts covered by pharmaceutical manufacturers.

FDA Foreign Inspections Curtailed

As foreign travel restrictions increased in response to the COVID-19 pandemic, the FDA announced that to protect employees, foreign site inspections of FDA-regulated manufacturing plants and products would be suspended. The FDA said it would conduct inspections at borders, if necessary, or rely more heavily on documentation, remote communications, and trusted manufacturers.

HHS Secretary Alex Azar spoke at the Biosimilars: Breaking Through the Barriers symposium in Washington, DC, about biosimilar uptake and how these agents could cut total healthcare costs. He said recent actions by HHS and the FDA have made it easier to achieve this objective. “Efficient review and earlier marketing of approved biosimilars have been the direct result of actions by the FDA under its Biosimilars Action Plan,” Azar explained.

Payment Incentives for Biosimilars

Despite ongoing challenges for the industry, Azar highlighted new biosimilar-related policies and guidance released by the FDA, as well as legislative efforts such as the Grassley-Wyden bill, which would increase Medicare Part B reimbursement for biosimilars from average sales price (ASP) plus 6% to ASP plus 8% for the first 5 years following introduction. This enhanced payment is intended to encourage use by providers.

The Breaking Through the Barriers symposium also featured 2 expert panels: one highlighted the need for more biosimilars to protect against possible drug shortages caused by COVID-19, and the second concerned policy actions that are needed to promote US biosimilar uptake.

COVID-19 and Clinical Trial Activity

As COVID-19 continues to spread, challenges such as quarantines, site closures, travel limitations, and supply chain interruptions for investigational products are likely to impact clinical trials.

During March, the FDA issued contingency guidance for trials affected by COVID-19. The guidance advised that clinical trial protocol modifications may be made but must be documented and promptly reported. The FDA noted that the guidance would help to ensure trial participant safety, maintain good clinical practices, and minimize risks to trial integrity.

And finally, on March 23, 2020, the regulatory transition changing the approval pathway for certain biologics went into effect. The change affected insulin and insulin analogues, human growth hormone, pancreatic enzymes, and reproductive hormones, which have historically been approved under new drug applications under the Federal Food, Drug, and Cosmetic Act.

The transition concludes a 10-year preparation period established by the Biologics Price Competition and Innovation Act of 2009 and will broaden the range of agents that can be approved as biosimilars.

The FDA hopes that more competition for established insulin products will emerge through this new regulatory pathway. The cost of insulin has been rising, making it more difficult for patients to meet their out-of-pocket expenses for treatment.

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