New Legislation Aims to Accelerate Slow Adoption of Biosimilars
Two new pieces of federal legislation aim to boost adoption of biosimilars — which has been slower than many hoped — by increasing public awareness of branded-biologic alternatives and making changes to the patent system. The PBM industry’s largest trade group praised the legislation, but experts say that, while the new laws are welcome, they are unlikely to change the complex pricing dynamics that make biologics and even biosimilars so expensive.
One of the laws, the Advancing Education on Biosimilars Act, would increase efforts by federal agencies to promote biosimilars among providers, patients and other health care stakeholders. The bill was sponsored by Sens. Bill Cassidy, M.D., (R-La.) and Maggie Hassan (D-N.H.). The Ensuring Innovation Act, introduced by Cassidy and Sens. Tina Smith (D-Minn.) and Roger Marshall, M.D., (R-Kan.) changes definitions in the Food, Drug, and Cosmetic Act to limit the ways that drug manufacturers can make alterations to drugs in order to extend the exclusivity of patents beyond their original term — a practice called “evergreening.” Both bills passed the House with large majorities and the Senate unanimously, although President Joe Biden has yet to sign them as of press time.