The Senate has passed a bill requiring the FDA to provide educational information that supports and promotes the adoption of biosimilars.
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.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.