The US Food and Drug Administration has approved Biocon Biologics India Ltd’s insulin glargine injection Semglee for controlling high blood sugar in adults with diabetes, the company said. Semglee, co-developed by Biocon Biologics and its partner Mylan, is a biosimilar to Sanofi’s Lantus insulin glargine injection.

‘The global INSTRIDE clinical studies have demonstrated no difference in safety, efficacy and immunogenicity of Semglee in comparison to the reference product, Lantus, in type 1 and type 2 diabetes,’ Christiane Hamacher, chief executive officer and managing director of Biocon Biologics, said.

Sanofi’s total sales for the year ending April was about $1.68 billion for Lantus 100 units/mL vial and around $4.33 billion for Lantus SoloSTAR Pen.

This is the third product of the Biocon subsidiary and Mylan that has been approved by the US FDA, after pegfilgrastim biosimilar Fulphila and trastuzumab biosimilar Ogivri. Biocon Biologics and Mylan are in pact to develop and market about a dozen biosimilar. The approval for Semglee follows a favourable ruling from the US Patent and Trademark Appeal Board (PTAB) in favour of Mylan in its dispute with Sanofi over four patents of their insulin injection pen.

Sanofi had challenged that Mylan’s device for insulin glargine product Semglee infringed the company’s patents for Lantus SoloSTAR. The PTAB, however, found Sanofi’s claims unpatentable.

Sanofi’s Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes for the control of high blood sugar, and the company sells the product in vials under the brand Lantus and disposable injection pens under the brand Lantus SoloSTAR.

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glargine injection , Semglee immunogenicity of Semglee, Lantus SoloSTAR , US Food and Drug Administration, US Patent and Trademark Appeal Board (PTAB)