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biocon

Prime Therapeutics to prefer Viatris’ interchangeable insulin biosimilar

November 3, 2021 By Sean Whooley

Viatris Biocon

Pharmacy benefit manager Prime Therapeutics announced today that it will prefer Viatris’ (NSDQ:VTRS) Semglee insulin biosimilar injection on its national formularies as part of the pharmacy benefit. In July, the FDA cleared the Semglee insulin glargine-yfgn injection, developed by Viatris in collaboration with Biocon Biologics, as a biosimilar for controlling high blood sugar in adults […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: biocon, Prime Therapeutics, Viatris

FDA approves insulin glargine biosimilar injection from Viatris, Biocon Biologics

July 29, 2021 By Sean Whooley

Viatris Biocon

Viatris (NSDQ:VTRS) and Biocon Biologics announced FDA clearance for their Semglee insulin glargine-yfgn injection as a biosimilar. Semglee holds an indication for controlling high blood sugar in adults with type 2 diabetes and pediatric patients with type 1 diabetes. The FDA approved Semglee as the first interchangeable biosimilar product under the 351(k) regulatory pathway. The […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: biocon, Viatris

Bicara Therapeutics launches with $40M investment

March 15, 2021 By Sean Whooley

Bicara Therapeutics

Bicara Therapeutics announced today that it has launched with a $40 million investment from Biocon Limited. Cambridge, Mass.-based Bicara’s financing is earmarked for the advancement of its pipeline of first-in-class bifunctional antibodies developed between an engineering team in Bangalore, India, and the Cambridge-based executive team, according to a news release. Bicara’s pipeline includes tumor-targeted antibodies […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Immunotherapy, Oncology, Pharmaceuticals Tagged With: Bicara Therapeutics, biocon

EU, Australia approve insulin glargine biosimilar

March 28, 2018 By Sarah Faulkner

Mylan

Mylan (NSDQ:MYL) and Biocon touted today that Semglee, their co-developed insulin glargine biosimilar, won approval in the European Union and in Australia. The product will be sold in a pre-filled disposable pen and is the first biosimilar from Biocon and Mylan to be cleared in Europe. Semglee will launch in Australia later this year, Mylan reported, […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: biocon, Mylan

European committee backs Mylan’s insulin glargine biosimilar

January 29, 2018 By Sarah Faulkner

Mylan

Mylan (NSDQ:MYL) and Biocon announced today that a European Medicines Agency committee has recommended approval for its biosimilar insulin glargine, Semglee. The committee’s positive opinion brings the product one step closer to approval. The European Commission is slated to make a final decision in April. “We are pleased with CHMP’s decision to recommend approval of Mylan […]

Filed Under: Diabetes, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: biocon, Mylan

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