3:12 a.m. July 29, 2021
- By Jaimy Lee
Viatris gets FDA approval of first biosimilar version of Sanofi's insulin LantusShares of Viatris Inc. gained 3.3% in premarket trading on Thursday, the day after the Food and Drug Administration approved the first biosimilar verson of insulin glargine from Viatris and Biocon Biologics Ltd. Biocon is a privately held biopharma company based in India. The newly approved treatment, Semglee, is a biosimilar and interchangeable version of Lantus, Sanofi's once-blockbuster long-actin insulin. Semglee will be sold exclusively by the companies for 12 months before the FDA can approve another biosimilar version of Lantus. Biosimilar drugs are copies of complex biologic drugs; this is somewhat similar to how generic drugs compare to brand-name prescription medications, in that that biosimilars and generic drugs are less expensive than the brand-name alternatives. Viatris shares are down 24.0% so far this year, while the broader S&P 500 is up 17.1%.
2:48 a.m. March 10, 2021
- By Jaimy Lee
Lannett plans to file experimental insulin product with FDA sometime this yearShares of Lannett Co. Inc. gained 7.3% in premarket trading on Wednesday after the company said it received feedback from the Food and Drug Administration about the ongoing development of a biosimilar version of insulin glargine. This type of long-acting insulin is considered a biologic and was initially developed by Sanofi under the brand name Lantus. Lannett said it submitted the clinical-trial protocol to the FDA in November and has since updated it with the regulator's feedback. The company plans to file an investigational new drug application sometime in 2021, with a goal to eventually launch the product in the market in 2023. Lannett's stock is down 15.3% over the past 12 months, while the S&p 500 has gained 41.1%.