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Biocon Biologics, Viatris Get USFDA Nod For 1st Interchangeable Biosimilar Insulin Product

The approval for the product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be introduced before the end of the year

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Biocon Biologics and Viatris on Thursday said the US health regulator has approved the first interchangeable biosimilar insulin product Semglee for the treatment of diabetes in the US.

The approval for the product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be introduced before the end of the year, the Biocon arm and Viatris Inc said in a statement.

'The United States Food and Drug Administration (USFDA) has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway,' it added.

The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway, the statement said.

Over the next few months, Viatris will transition the current product to the interchangeable product, it added.

'We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the US. It is a milestone achievement for both Biocon Biologics and our partner Viatris,' Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said.

This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality biosimilar insulin glargine, she added.

'We are extremely proud to achieve the industry’s first approval of an interchangeable biosimilar product in the US, which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers,' Viatris CEO Michael Goettler said.

Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes.

Viatris and Biocon Biologic's insulin glargine has received regulatory approval in more than 60 countries around the world and was the third product approved by the FDA through the Viatris-Biocon Biologics collaboration, the statement said.

In an announcement on Wednesday, the US health regulator had said that Semglee is the first interchangeable biosimilar product approved in the US for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

'This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,' Acting FDA Commissioner Janet Woodcock said.

As per the USFDA, a biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA.

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber, it added.

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state, USFDA said.

Viatris and Biocon Biologics have an exclusive collaboration for the development, manufacturing and commercialisation of a broad portfolio of biosimilars and insulin analogs.

While Viatris has exclusive commercialisation rights in the US, Canada, Australia, New Zealand, the European Union and European Free Trade Association countries, Biocon Biologics has exclusive commercialisation rights for Japan and certain emerging markets.

Viatris and Biocon Biologics have co-exclusive commercialisation rights in the rest of the world. 


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