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PITTSBURGH and BENGALURU, India, July 28, 2021 /PRNewswire/ Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee
® (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway.
Biocon Biologics
Viatris CEO Michael Goettler commented: We are extremely proud to achieve the industry s first approval of an interchangeable biosimilar product in the U.S., which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers. This is yet another important milestone for our company that not only continues to underscore the strength of our internal scientific capabilities, but also supports our belief in the promising future of our company as we continue to work to identify innovative ways to increase access to complex treatments f
Biocon s Semglee gets USFDA approval; first interchangeable biosimilar product in US
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Last Updated: Jul 29, 2021, 09:56 AM IST
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Synopsis
“It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine,” Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said in a statement.
The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
Biocon Biologics Ltd, a unit of Biocon and Viatris Inc said on Thursday that the U.S. Food and Drug Administration (FDA) has approved its insulin glargine-yfgn injection branded Semglee in the US market.