Mylan and Biocon's Follow-On Insulin Glargine Recommended for European Approval

On Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on and recommended a marketing authorization for Mylan and Biocon’s Semglee, an insulin glargine follow-on that will be available in the European Union as a solution for injection for patients with diabetes.

The drug will now be referred to the European Commission, which is expected to grant a final marketing authorization for the product. If approved, Semglee, referenced on Lantus, will compete with other biosimilars of insulin glargine, including Lusduna, approved for marketing in the EU in January 2017, and Abasaglar, approved in September 2014.

The positive CHMP opinion follows the June 2017 release of data from the INSTRIDE studies at the American Diabetes Association Scientific Sessions, which confirmed the efficacy, safety, and immunogenicity of Semglee in comparison to Lantus in patients with type 1 and type 2 diabetes. Shortly after the INSTRIDE data were reported, Biocon received a certificate of compliance from the European Union for its manufacturing facility in Malaysia, where it plans to produce the insulin product.

In the US marketplace, where Mylan and Biocon also hope to gain approval for the drug, Sanofi, maker of the reference product, has sued Mylan over the biosimilar. Sanofi’s suit alleges that Mylan infringed on 18 patents for the drug after Mylan filed a New Drug Application for the product with the FDA (in the United States, insulins are regulated as drugs and not as biologics; hence, drug makers must submit NDAs rather than biologics license applications for follow-ons of originator products). According to Sanofi, the Mylan NDA included a challenge to all of Sanofi’s patents listed for Lantus in the FDA’s orange book.