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 […]
biocon
FDA approves insulin glargine biosimilar injection from Viatris, Biocon Biologics
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 […]
Bicara Therapeutics launches with $40M investment
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 […]
EU, Australia approve insulin glargine biosimilar
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, […]
European committee backs Mylan’s insulin glargine biosimilar
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 […]
