Biocon-Viatris obtain USFDA nod for first interchangeable insulin

August 12, 2021:

Biocon Biologics aims to improve access to affordable insulin for diabetes patients in the US market, as the company, with its partner Viatris, has received approval for Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product.

The interchangeable Semglee product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be introduced before the end of the year and commercial preparations for that are underway.

Biocon Biologics, through Viatris, is eligible to have exclusivity for 12 months before the United States Food and Drug Administration (USFDA) can approve another biosimilar interchangeable to Lantus.

The “game-changing” approval would allow “pharmacy level substitution” for insulin glargine in the US thereby providing convenient and affordable access to biosimilar insulin glargine, said Kiran Mazumdar-Shaw, executive chairperson, Biocon Biologics.

This means the interchangeable biosimilar product can be substituted for the reference product by the pharmacist without the intervention of prescriber, akin to how generic drugs are substituted for brand name ones.

“In the US insulin pricing has always been challenging for the uninsured patients and I think we want to make a difference there with this game-changing approval. Therefore, our marketing strategy will also reflect that,” said Mazumdar-Shaw, adding, “We are extremely proud to be the first to obtain approval of an interchangeable biosimilar product in the US. It is a milestone achievement for both Biocon Biologics and our partner Viatris.”

Research papers have highlighted that the US market witnessed an exponential increase in the prices of all insulins between 2002 and 2016.

According to a news release on the interchangeability approval by USFDA, biosimilar and interchangeable biosimilar products have the potential to reduce healthcarecostsin the US, a nation with more than 34 million diabetes patients.

“This interchangeability approval for Semglee by the USFDA, another first to our credit, is a testament to our scientific excellence and robust quality comparability data,” said Arun Chandavarkar, managing director, Biocon Biologics, the biosimilar subsidiary of Biocon.

Financial Express