US FDA approves first interchangeable biosimilar

Semglee is an insulin product indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.

Co-developed by Mylan [now Viatris] and Biocon Biologics, Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with its reference product Lantus (insulin glargine), said the US regulatory body. 

The interchangeable designation means that Semglee can also be substituted for Lantus automatically by pharmacists without physicians' permission, as per state laws.

As per standard practice in the US for biosimilars, the FDA has added a suffix to the nonproprietary name; in this case Semglee will be referred to as ‘insulin glargine-yfgn.’

Competitive marketplace 

The US market for insulin biosimilars​​ only opened up in 2020. In contrast, in Europe, the first insulin biosimilar got approval in 2014.

Acting FDA Commissioner Janet Woodcock, said this regulatory milestone “furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”​

Biosimilars marketed in the US typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products, noted the FDA.

Though the US regulator approved Semglee in August 2020, and Biocon Biologics and Viatris then launched the insulin drug on the US market, the product did not have biosimilar or interchangeable status as it was not approved under the biosimilar pathway in the Biologics Price Competition and Innovation Act (BPCIA). The companies, thus, subsequently sought that biosimilar and interchangeable status noting the competitive advantage such designations would bring. 

Biocon Biologics executive chairperson, Kiran Mazumdar-Shaw said the approval represents a milestone achievement for the partners. "This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee."​

Safety and effectiveness​

Semglee, offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily.​

The approval of that insulin product as biosimilar to, and interchangeable with Lantus is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between Semglee and Lantus in terms of safety and effectiveness, said the US watchdog.

That data also showed that Semglee can be expected to produce the same clinical result as Lantus in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee and Lantus is not greater than the risk of using Lantus without such switching, it said.

In tandem with the approval of that insulin product, the FDA also released new materials for US health care providers with the goal of boosting understanding of biosimilar and interchangeable biosimilar products. Fact sheets and videos are included.