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November 28, 2022

FDA Approves Lantus® Interchangeable Biosimilar

By Kevin E. Noonan --

FDAOn November 18th, the U.S. Food and Drug Administration (FDA) announced its approval of Eli Lilly's Rezvoglar (insulin glargine-aglr) product as an interchangeable biosimilar to Sanofi's Lantus (insulin glargine).  Both the reference product and the interchangeable biosimilar are "long-acting human insulin analog[s] indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus" according to FDA's press release.  Rezvoglar had been approved on December 17, 2021 as a biosimilar, and with this approval joins Semglee (insulin glargine-yfgn), which was the first approved Lantus-interchangeable biosimilar.  The Rezvoglar product will be marketed as 3 mL prefilled injectable pens.

This approval brings to four the number of approved interchangeable biosimilar products; in addition to Semglee, these include Cyltezo (adalimumab-adbm), an interchangeable biosimilar to AbbVie's Humira (adalimumab) and Cimerli™ (ranibizumab-eqrn), an interchangeable biosimilar to Genentech/Roche's Lucentis® (ranibizumab).

Posted at 11:07 PM in Biosimilars, Food and Drug Administration |

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