Biocon Biologics and Mylan Announce U.S. Launch of Insulin Glargine Product Semglee

Rothwell, Figg, Ernst & Manbeck, P.C.

Pharmaceutical companies Biocon Biologics and Mylan announced at the end of last month the U.S. launch of their long-acting insulin glargine product Semglee. Semglee was approved in June as an equivalent to Sanofi’s reference product insulin glargine, Lantus.

The companies are launching Semglee at a “65% discounted list price,” calling it the lowest wholesale acquisition cost for any long-acting insulin glargine on the market. Mylan, the distribution partner, is offering Semglee at the wholesale acquisition cost of $147.98 per package of five 3mL pens and $98.65 per 10mL vial. For reference, the individual vial cost of Lantus was $431 in 2019 according to a Senate Finance Committee letter. It should be noted, however, that wholesale acquisition cost does not necessarily reflect the actual cost to consumers or healthcare providers.

Both companies expressed the intention to have Semglee formally approved as a biosimilar to Lantus, and were confident that Semglee would receive interchangeability designation. Both designations would accelerate the competition in the insulin market. Mylan stated that all necessary documentation to request approval of Semglee as a biosimilar to Lantus has already been submitted to the FDA.

Kiran Mazumdar-Shaw, Executive Chairperson of Biocon, commented that the launch “represents another milestone achievement for Biocon in making insulin-based therapy increasingly accessible for people with diabetes globally. We are confident that along with our long-standing partner Mylan, we will be able to address the needs of millions of patients living with diabetes in the U.S.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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