Biosimilars Education Bill Gains Senate Approval

The US Senate has passed a bill that would require the FDA to beef up education on biosimilars in order to improve uptake of these lower-cost agents, which are considered as safe and efficacious as the originator biologics they are patterned after.

The Advancing Education on Biosimilars Act was approved unanimously. The bill (S 1681) was co-sponsored by Senator Maggie Hassan, D-New Hampshire. “Our bipartisan legislation will help lower the cost of health care by educating more Granite Staters and Americans about biosimilars—an under-the-radar alternative to expensive brand-name drugs,” Hassan said in a statement.

The Senate version of the bill was introduced in May 2019 and was voted on successfully in December 2020 but required a fresh vote this year.

Under the bill, the FDA would be required to create a biosimilars education website with information on biosimilars and other biologics covering key statutory and regulatory terms used to describe and classify biosimilars, such as interchangeability. It would have to be tailored to the unique needs of health care providers, meaning the material should be appropriately presented and explained.

The bill would also require that comparative data for originator biologics and biosimilars is made available; and, on an ongoing basis, continuing education programs would have to be maintained to inform health care providers, including nurses, about biosimilars.

A House version of the bill (HR 4400) was introduced in September 2019 and referred to the Subcommittee on Health.