Updates in Biosimilar Legislation and Regulation

To date, 41 states and Puerto Rico have laws for biosimilars. However, federal and state regulations on biosimilars are confusing, incomplete, and often discourage adoption, according to a presentation by Reginia Benjamin, BS, JD, director of legislative affairs at AMCP, and Edward Li, PharmD, MPH, BCOP, professor at the University of New England College of Pharmacy in Maine, at AMCP Annual Meeting 2018. They discussed recent developments regarding these therapies.

State legislative language around biosimilars include:

  • Required notice to the patient prior to dispensing, with a time frame that ranges from 24 hours to five years;
  • Additional labeling requirements and retention timeframes;
  • Approval by the patient prior to dispensing;
  • State Board of Pharmacy must maintain information its website of U.S. Food and Drug Administration (FDA)-approved interchangeable biosimilars; and
  • A pharmacist who selects an equivalent drug product or interchangeable biologic assumes no greater liability than would be incurred in filling a prescription for a reference agent.

On the federal level, the Biosimilar User Fee Act (BsUFA) Reauthorization was signed into law in 2017 (BsUFA II) and requires the FDA to review and act on 90% of original biosimilar biologic applications within 10 months of the 60-day filing date. This is intended to allow for more communication across the entire application cycle. Under BsUFA II, an independent fee structure is established for biosimilars, increasing from $22 million in 2017 to $87 million in 2018 to ease the workload of the FDA in reviewing these agents.

Patent litigation and settlement agreements are delaying significant market launches of many agents until 2022 and 2023. But, Dr. Li said, that improvements within BsUFA are likely to help speed the approval of these agents.

Data from Europe are showing that biosimilars have led to decreased costs and increased access to biologics. In the United States, concerns remain that need to be addressed, such as clarity and support for switching and an understanding of off-label use.

Education and stakeholder engagement are essential to the successful adoption of these agents. The Biosimilar Resource Center (biosimilarsresourcecenter.org/) provides educational resources in a policy-neutral and non-promotional manner.

Presentation L7: A Biosimilars Update: Regulation and Legislation. AMCP Annual Meeting 2018.