Biocon Biologics and Viatris’s Semglee preferred on Express Scripts’ largest formulary in US

Biocon Biologics yesterday announced that Express Scripts, a leading pharmacy benefit management organisation in the US, will list Biocon Biologics interchangeable biosimilar insulin glargine (Semglee), which will be commercialised by Viatris, as a preferred glargine brand on its National Preferred Formulary (NPF), which includes more than 28 million lives.

In a statement, Biocon Biologics said that broad coverage of Semglee by Express Scripts will help ensure that the many patients on its network who need Insulin Glargine may receive the full benefits of and access to treatment with lower or maintained out-of-the-pocket costs.

Viatris will soon commercialise two versions of Insulin Glargine injection. 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 Program. This dual product approach is intended to ensure that this interchangeable biosimilar Insulin Glargine can reach as many patients as possible regardless of financial circumstances, insurance or channel, the statement further said.

Commenting on this development, Dr Arun Chandavarkar, Managing Director, Biocon Biologics, said, “The inclusion of our interchangeable biosimilar Insulin Glargine in Express Scripts’ National Preferred Formulary (NPF) in the US is a major milestone for Biocon Biologics. It furthers our mission of enabling affordable access to quality insulins to a large number of patients. 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 Biocon Biologics.”

He added, “We believe adoption of biosimilars through PBMs like Express Scripts, will drive down the high cost of biologics therapy for chronic diseases like diabetes. Our biosimilar Insulin Glargine has the potential to bring significant cost savings for patients, employers and PBMs,” he added.

The statement notified that in July 2021, the US Food and Drug Administration (FDA) had approved the company’s biosimilar Insulin Glargine-yfgn injection (Semglee) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.

Semglee (insulin glargine-yfgn) injection and Insulin Glargine-yfgn injection will be available in pharmacies before the end of the year, and further details related to Viatris’ access programmes, which aim to ensure that as many patients as possible will benefit from the product, will be available at that time. The Express Scripts formulary change, including coverage of Semglee (insulin glargine- yfgn) on NPF, will occur effective 1st January, 2022, the statement concluded.