Biocon Biologics, Viatris interchangeable biosimilar Insulin Glargine preferred on Express Scripts' largest formulary in US

Bengaluru: Biocon Biologics Limited, a subsidiary of Biocon Ltd. has recently announced that Express Scripts, a pharmacy benefit management organization in the US, will list Biocon Biologics interchangeable biosimilar Insulin Glargine (Semglee* ), which will be commercialized by Viatris, as a preferred glargine brand on its National Preferred Formulary (NPF), which includes more than 28 million lives.

"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-pocket costs", the relerase said.

Biocon Biologics co-developed Semglee with Viatris. Viatris will soon commercialize two versions of Biocon Biologics landmark Insulin Glargine injection, the first-ever interchangeable biosimilar approved by the U.S. Food and Drug Administration (USFDA): Semglee (insulin glargine-yfgn) injection, a branded interchangeable product, and Insulin Glargine (insulin glargine-yfgn) injection, an authorized 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 Program.

"This dual product approach is intended to ensure that this historic interchangeable biosimilar insulin glargine can reach as many patients as possible regardless of financial circumstances, insurance or channel," the company added.

Commenting on this marquee 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 U.S. 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 commercialize the product in the U.S. by end of the year and formulary coverage to begin in Jan 2022, making it an important growth driver for Biocon Biologics."

"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.

In July 2021, the U.S. Food and Drug Administration (USFDA) had approved biosimilar Insulin Glargine-yfgn injection (Semglee) as the first interchangeable biosimilar product under the 351(k) regulatory pathway, endorsing scientific excellence and robust quality comparability data. Semglee* (insulin glargine-yfgn) Injection and Insulin Glargine-yfgn Injection will be available in pharmacies before the end of the year. The Express Scripts formulary change, including coverage of Semglee* (insulin glargineyfgn) on NPF, will occur effective January 1, 2022.