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Biocon's insulin biosimilar Glargine gets preference in top US formulary

The USFDA had approved biosimilar Insulin Glargine-yfgn injection (Semglee) as the first interchangeable biosimilar product in July this year

Biocon | USFDA

Deepsekhar Choudhury 


An insulin biosimilar called Glargine, co-developed by Biologics and US pharma company Viatris, will be listed by pharmacy benefit management organisation Express Scripts as a preferred insulin brand on its National Preferred Formulary for diabetic patients in the US.

Drug formularies are a set of generic and brand name medicines which are preferred by a health plan. They help patients in choosing a less expensive drug when a cheaper alternative could be used to treat a condition just as well.

“The inclusion of our interchangeable biosimilar insulin glargine in Express Scripts’ National Preferred Formulary (NPF) in the US is a major milestone for Biologics. We expect our partner to commercialise the product in the US by the end of the year and formulary coverage to begin in January 2022, making it an important growth driver for Biologics,” said Dr Arun Chandavarkar, managing director, Biocon Biologics.

In July 2021, the had approved biosimilar Insulin Glargine-yfgn injection (Semglee) as the first interchangeable biosimilar product under the 351(k) regulatory pathway. An interchangeable biosimilar is said to be “highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA”.

Viatris will soon commercialise two versions of the injection: Semglee injection, a branded interchangeable product, and Insulin Glargine injection, an authorised interchangeable biosimilar. Both products will be available in pen and vial presentations and are interchangeable for the reference brand, Lantus. Semglee will also be included in Express Scripts' Patient Assurance Programme.

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First Published: Thu, October 21 2021. 12:19 IST