One company that received approval for an insulin biosimilar in the US is Viatris, for its Semglee (insulin glargine-yfgn) product. In a recent fourth quarter investor call, Sanjeev Narula ...

Monica Chou, Damineh Morsali PH.D., Robert Schwartz Ph.D.

U.S. FDA approves Biocon’s insulin Semglee It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any member state ...

The FDA approved Semglee in 2021, the first interchangeable biosimilar insulin, four years after the manufacturer submitted its initial application and two-and-a-half years after the manufacturer ...

These biosimilars are also competing against insulin glargine products that were approved prior to the passing of the biosimilar approval pathway, including Toujeo (Sanofi), Rezvoglar (Eli Lilly), ...

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference ...