Legislation paves way for FDA’s approval of 1st generic insulin product
Published 12:00 am Saturday, July 31, 2021
WASHINGTON – U.S. Senators Bill Cassidy, M.D. (R-LA) and Tina Smith (D-MN) have long pushed to bring lower-cost insulin to market, and the senators highlighted the Food and Drug Administration’s approval of the first generic insulin product that will rein in costs after years of significant increases. Wednesday’s approval by the FDA is due in part to Sens. Smith and Cassidy’s bipartisan bill the Protecting Access to Biosimilars Act enacted in 2019.
“There are heartbreaking stories of people forced to ration their expensive insulin who ultimately went into a diabetic coma or even died. We begin to address this by making insulin more affordable. Generic insulin will help make this happen. This is a great step forward for patients,” said Dr. Cassidy.
In December 2018, the FDA issued guidance for transitioning insulin from being classified as drugs to biosimilars—which are medical products that are almost an exact copy of a product originally manufactured by a brand-name company. The guidance provided a number of useful clarifications regarding the new drug approval pathway for biosimilar products, and issued clarification on the transition to prevent evergreening (when brand-name companies patent slight changes of old drugs and call them new drugs in order to control the market) and other tricks companies use to extend their exclusivity period.
Sens. Smith and Cassidy’s legislation made sure this guidance stayed in place. And now, the FDA has determined that a lower-cost insulin product is biosimilar to another brand-name insulin product. This means that patients can purchase the lower-cost option without needing a separate prescription, similar to how pharmacies substitute generics for other, pricier prescription drugs.