Axinn IP Chair Provides Analysis of Biden Biosimilars Initiative

On July 9, 2021, President Biden signed a sweeping executive order intended to promote a more vibrant and competitive economy. The mandate contained provisions that affect the biosimilars market.

For insight into the significance of these initiatives, The Center for Biosimilars® spoke with Chad Landmon, JD, chair of the Intellectual Property and FDA Practice groups at Axinn, Veltrop & Harkrider, a law firm specializing in antitrust and intellectual property issues based in New York.

The executive order calls for the importation of drugs from Canada to help improve supply and lower prices in the United States. It also directs HHS to support the use of generic and biosimilar agents, and it increases pressure on the Federal Trade Commission to oppose “pay-for-delay” agreements that pharmaceutical companies sometimes employ to keep rival products off the market.

Among its provisions, the executive order also calls upon HHS to produce a comprehensive plan within 45 days to address high prescription drug prices and “price gouging.”

Landmon put these initiatives into context with background information and insight into the likely pharmaceutical industry impact and response.

He discusses the complications inherent in tackling pay-for-delay settlements as these, while not ideal, do carry the benefit of offering parties to a pharmaceutical dispute a way to set a timeline for bringing products to market, thereby avoiding costly litigation that could prevent lower-cost drugs from entering the market for substantially longer periods of time.

Landmon mentions California’s landmark anti–pay-for-delay legislation, signed into law in 2019, that prevents “anything of value” from being exchanged by pharmaceutical companies in exchange for a settlement. This law survived its first legal challenge last year when a federal judge denied a motion for relief by the Association for Accessible Medicines (AAM), a group representing generics and biosimilars manufacturers.

The AAM in a statement issued July 9, 2021, said it is willing to work with the Biden administration to accelerate adoption of lower-cost generics and biosimilars but wants to avoid extension of restrictions on drug dispute settlements such as California has imposed. “The White House should ensure that any new regulations do not restrict the ability to settle patent litigation with brand companies in a procompetitive manner,” the AAM said.

Drug imports from Canada were authorized during the Trump administration. For a recent Center for Biosimilars® article outlining the pros and cons of this initiative, click here.