BENGALURU: The
US Food and Drug Administration
(
FDA
) said it gave a nod to Biocon Biologics and Viatris'
biosimilar
insulin product,
Semglee
, which can be used in adults and pediatric patients suffering from Type 1 and 2 diabetes mellitus.
Semglee is the first interchangeable biosimilar product approved in the US which is supposed to help patients get access to lower cost diabetes medicines.
The approval is a shot in the arm for Biocon Biologics, the biosimilar arm of the biopharmaceutical company, which has been betting big on the sale of such products in the US, the biggest market.
"We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S. It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine," said Kiran mazumdar-Shaw, executive chairperson of Biocon.
The interchangeable product, to be available at pharmacies, will be introduced before the end of the year. Biocon Biologics is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to the main product Lantus.
Biosimilars or biologics are drugs made from complex molecules manufactured using living microorganisms, plants, or animal cells. Though there are no differences in terms of safety and effectiveness from the main product, they are not considered duplicates, like generics, as it is impossible to manufacture exact copies of biotech drugs.
Biologics, is the largest contributor to Biocon's topline, and the fastest growing, as over the last few years many of its drugs received commercial approval in the mature markets of US and Europe. It is also looking to spin-off the business and take it public.
“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said acting FDA commissioner Janet Woodcock.
Start a Conversation
Post comment