On March 1, Eli Lilly was the first to announce U.S. list price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month. Lilly’s announcement noted that, effective May 1, it will…
As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of its acquisition in a part-cash/part-equity transaction. Under the terms of this USD $3.335 billion deal, Biocon paid…
On November 16, FDA approved Eli Lilly’s REZVOGLAR (insulin glargine-aglr) as the second interchangeable biosimilar to LANTUS (insulin glargine), joining SEMGLEE (insulin glargine-yfgn), which was previously approved as interchangeable to LANTUS. Regarding REZVOGLAR’s approval as interchangeable, FDA stated: “This approval furthers FDA’s longstanding commitment to support a competitive marketplace for…
On July 5, Mylan announced another voluntary recall of a batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens “due to the potential for the label to be missing on some pens.” The recalled product is not the branded SEMGLEE® pen, but rather the unbranded…
Lannett Company Announces Initiation of Pivotal Clinical Trial for Biosimilar Insulin Glargine On March 29, 022, Lannett Company (NYSE: LCI) announced the initiation of its pivotal clinical trial of biosimilar insulin glargine, which is being co-developed with Lannett’s strategic alliance partners within the HEC Group of companies. Lannett reported that…
Lannett Company, Inc. (“Lannett”) announced Friday that the FDA has completed its safety review of Lannett’s Investigational New Drug application for Lannett’s insulin glargine biosimilar, a product Lannett is co-developing with its strategic alliance partners within the HEC group of companies, and has concluded that the company may proceed with…
It has been reported that U.S. pharmacy benefit manager CVS will drop Sanofi’s insulin drugs, Lantus® (insulin glargine injection, 100 units/ml) and Toujeo® (insulin glargine injection, 300 units/ml) from the list of medications for which it reimburses on behalf of health insurers. In July CVS caremark® published a list of…
On March 10, Lannett announced that it received feedback from the FDA regarding its insulin glargine biosimilar. Lannett sought and received comments from the FDA concerning the protocol and statistical analysis plan to be used in the pivotal clinical trial for the product. Lannett reported that it incorporated this feedback…
Last week, Biocon Ltd announced the approval of approximately a 150 million USD capital injection from Goldman Sachs. Dr. Christian Hamacher, CEO, Biocon Biologics, said, “This capital injection by Goldman Sachs will enable us to make prudent investments in R&D, high-quality manufacturing, as well as, establish a global commercial footprint.” …
We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection). Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market. SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product. SEMGLEE will be available in vials and pre-filled pens. The lead…