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FDA approves first interchangeable biosimilar insulin product europeanpharmaceuticalreview
July 30, 2021
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
FDA Approves Biosimilar Interchangeable Insulin Treatment for Diabetes americanpharmaceuticalreview
July 30, 2021
The FDA approved the first interchangeable biosimilar product, Mylan’s Semglee (insulin glargine-yfgn). Semglee (insulin glargine-yfgn) is both biosimilar to and interchangeable with Lantus (insulin glargine).
Biocon Biologics and Viatris receive US FDA approval for maiden interchangeable biosimilar Semglee expresspharma
July 30, 2021
Interchangeable designation allows substitution at the pharmacy counter for Lantus across the US to help increase access to medicines for people living with diabetes.
FDA grants interchangeable status to Viatris' biosimilar insulin Semglee firstwordpharma
July 29, 2021
The FDA announced Wednesday that Viatris' biosimilar insulin product Semglee (insulin glargine-yfgn) may now be substituted for its reference product, Sanofi's long-acting insulin analogue Lantus (insulin glargine), without the intervention of a prescribe
Mylan, Biocon Biologics Announce Launch of Semglee in U.S. americanpharmaceuticalreview
September 01, 2020
Mylan and Biocon Biologics India announced the U.S. launch of Semglee™ (insulin glargine injection) in vial and pre-filled pen presentations, approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with...
Biocon Biologics and Mylan launch Semglee (insulin glargine injection) in US expresspharma
September 01, 2020
Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five 3ml pens and $98.65 per 10ml vial.
Biocon and Mylan receive US FDA approval for Semglee, an insulin glargine injection expresspharma
June 12, 2020
FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions of Americans living with diabetes-1.
Biocon’s partner Mylan receives favourable ruling from US PTAB on Sanofi’s four device patents for L expresspharma
June 02, 2020
Reportedly, the PTAB also found Sanofi’s proposed amended claims for the ‘486 and ‘844 patents unpatentable.
Biocon, Mylan win patent litigation for Insulin Glargine device patent in the US expresspharma
March 12, 2020
Brings Biocon closer to commercialising Semglee in the US in 2020.