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The US Food and Drug Administration (FDA) has approved the first-ever interchangeable biosimilar product, an insulin treatment for Types 1 and 2 diabetes.
The FDA defines biosimilars as biologic drugs which are highly similar to and have no “clinically meaningful difference” to the reference product. Viatris’ (formerly known as Mylan) Semglee (insulin-glargine yfgn) can now be substituted for Lantus, the original reference drug sold by Sanofi.
Viatris said it expected to have exclusivity for 12 months before the FDA could approve another interchangeable biosimilar for Lantus.
“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said acting FDA commissioner Janet Woodcock.
“Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” Woodcock added.
Viatris CEO Michael Goettler said the company was “extremely proud to achieve the industry's first approval of an interchangeable biosimilar product in the US, which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers”.
The FDA has made increasing the level of competition in the biologics market a priority, both through the approval of new generic products, and cracking down on anti-competitive behaviour.
The agency teamed up with the US Federal Trade Commission last year to warn biologics makers against falling foul of antitrust law, citing the need to bring down prices.
Biologics are among the most expensive drugs on the market, with a 2020 Clarivate Analytics report predicting that more than half of new ‘blockbuster’ drugs would fall into the biologics category.
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Food and Drug Administration, Lantus, Viatris, biosimilar, interchangeable, insulin, biologics, Sanofi, FDA, generics, competition, diabetes