UPDATED Monday, April 26, 2021, 9:00 a.m. EDT—President Biden signed the two bills into law on April 23.
The U.S. House of Representatives passed two bills last week intended to reduce the overall costs of medications by boosting competition for generic drugs and biosimilars. As both bills were previously passed by the Senate, they are headed to President Joe Biden’s desk for his signature.
The Ensuring Innovation Act (S. 415) is intended to close loopholes that have stifled competition from generic brands in recent years by modifying portions of the Food, Drug and Cosmetic Act (FDCA). The key revision is the FDCA’s standard for product exclusivity. The new law changes the standard from the active ingredients in each drug to active “moiety”—essentially its chemical composition at the molecular level. That would bar many manufacturers from claiming product exclusivity by simply altering some ingredients in an existing drug.
“The current regulatory landscape unnecessarily delays patient access to FDA-approved generics,” said Sen. Roger Marshall (R-Kan.) and one of the bill’s co-sponsors. “Our bipartisan legislation ensures affordable life-saving medicine while preserving innovation for cutting-edge medicine, and I’m pleased we are one step closer to this becoming law.”
The Advancing Education on Biosimilars Act (S. 164) would direct the Centers for Medicare & Medicaid Services to create a website and other educational materials for the public to educate them on what biosimilars are and how they can be used.
Widespread use of biosimilars could cut drug spending in the U.S. by as much as $150 billion over a decade, according to a 2018 study by the Rand Corp. However, few laypersons are aware that they exist and what they do.
“Currently many doctors and patients in New Hampshire and across the country are in the dark about this affordable option,” said Sen. Maggie Hassan (D-N.H.), one of the bill’s co-sponsors. “I am glad that both chambers have passed our bipartisan legislation to improve education about biosimilar products.”