Biocon’s insulin glargine approved by US pharmacy benefits manager

Biocon subsidiary Biocon Biologics Limited (BBL) said its insulin substitute Insulin Glargine has been included by Express Scripts — a prominent ‘pharmacy benefits manager’ in the US — in its National Preferred Formulary.

Pharmacy benefits manager, as the name implies, is a kind of outsourced service provider that manages pharmacy benefits extended to employees by corporations.

Bicon said the National Preferred Formulary routes pharmacy benefits to around 28 million people.

Biocon Biologics called the inclusion a major milestone 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…

“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 Indian company said.

Semglee was codeveloped by Biocon in association with Viatris.

As part of this commitment, Viatris will commercialize two versions of the product — Semglee injection, a branded interchangeable product, and Insulin Glargine injection, an authorized interchangeable biosimilar.

An interchangeable biosimilar may be substituted for a reference product by the pharmacist and can drive conversion to biosimilars at the pharmacy counter.

Viatris is expected to commercialize the product in the U.S. by end of the year and formulary coverage to begin in Jan 2022.

Both products will be available in pen and vial presentations and are interchangeable for the reference brand, Lantus.

“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,” it said. If the company had only brought out a branded product, it would have restricted the reach, and therefore seems to have decided to bring out both a branded version as well as a generic or biosimilar version.

In July 2021, the U.S. Food and Drug Administration (FDA) approved the company’s Insulin Glargine-yfgn injection (Semglee) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.

Express Scripts, Inc. is one of the largest PBMs in North America, providing services to thousands of managed-care organizations, insurance carriers, employers, third-party administrators, public sector, workers compensation, and union sponsored benefit plans.

Semglee is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.