CPhI Online

- Biopharma News

Viatris and Biocon score historic first for interchangeable biosimilar product

2 Aug 2021

The new approval of Semeglee allows pharmacy-level substitution for Lantus across the US

The US Food and Drug Administration has approved Biocon and Viatris' Semglee (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway.

The interchangeable Semglee product is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. It has an identical amino acid sequence to Lantus and is approved for the same indications.

Semglee was first approved in June last year, but this new approval means it is completely interchangeable with the reference product, Lantus, at the pharmacy counter.

Viatris, which will have 12 months' exclusivity before the FDA can approve another biosimilar interchangeable to Lantus, has already started commercial preparations for launch, which is expected before the end of the year.

During the next few months, the company will transition the current product to the 351(k) interchangeable product.

Viatris is the newly formed company that resulted from the combination of Mylan and Upjohn (a division of Pfizer) in July 2019.

The exclusive collaboration between Viatris and Biocon Biologics (a subsidiary of Biocon) focuses on developing, manufacturing and commercialising a broad portfolio of biosimilars and insulin analogues. The insulin glargine is the collaboration's third product to receive FDA approval.

Related Content