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Semglee Insulin Gains Automatic Approval under BPCIA


In gaining FDA approval, the insulin glargine product Semglee receives automatic status as a biologic under the Biologics Price Competition and Innovation Act (BPCIA), although it was approved as a 505(b)(2) product under the Food Drug and Cosmetic Act. Semglee becomes the first insulin glargine under the 351(a) pathway.

The FDA has approved an insulin glargine (Semglee) under the generic 505(b)(2) New Drug Application pathway, and the drug automatically is deemed a biologic under section 351(a) of the Public Health Service Act of the Biologics Price Competition and Innovation Act (BPCIA), based on a policy enacted March 23, 2020. The drug references Sanofi’s Lantus.

Mylan and Biocon Biologics, which co-developed the agent, said they intend to seek “interchangeable” status for it, meaning pharmacists could fill prescriptions with Semglee without consulting the prescribing physician.

Semglee is approved in vial and and prefilled pen applications to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes. “Semglee has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications,” Mylan and Biocon said in a statement.

"This approval is an important milestone, first and foremost for the millions of patients living with diabetes in the United States as we seek to expand their access to insulin through more affordable treatment options,” said Mylan CEO Heather Bresch. “It's also another milestone for Mylan as we continue to leverage our scientific, commercial, manufacturing and regulatory expertise to benefit patients, and as we enhance our portfolio with increasingly complex and higher value-chain products, like insulin.”

“We look forward to making this product available to patients in the United States as soon as possible," Mylan President Rajiv Malik said.

Mylan and Biocon said the product remains “at risk” of further litigation.

“Favorable judgments on all remaining patent claims asserted by Sanofi against Mylan's insulin glargine products have been obtained. Although Sanofi may seek certain appeals of those judgments, Mylan is confident they will not affect commercialization plans,” the companies said in the statement.

Lantus revenue for the 12 months ending April 30, 2020, was roughly $6 billion, according to Mylan and Biocon.

In October, Biocon and Mylan launched Semglee in Australia. The country has allowed the product to be substituted at the pharmacy level without consulting with the prescribing physician.

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