Biopharmaceutical firm Biocon is one step closer to commercialize its glargine biosimilar Semglee in the US.
Biopharmaceutical giant Biocon announced on March 11, 2020, that it with its partner Mylan won a litigation in a US court that has invalidated a Sanofi patent on a device for delivering insulin glargine. This makes it easy for Biocon to commercialize its glargine biosimilar Semglee in the US. The verdict removed a major legal hurdle for the commercialization of the product that has been co-developed by the two companies for the US market.
The device patent claims (US Patent No. 9,526,844) that Sanofi asserted against insulin glargine product of Biocon-Mylan was found to be not infringed’ and ‘invalid’ by the US District Court of New Jersey for lack of written description.
Earlier the Sanofi’s formulation patents US Patent No. 7,476,652 and 7,713,930 were invalidated by the Federal Circuit – the higher court.
The partners- Biocon and Mylan filed for insulin glargine through 505(b)(2) New Drug Application (NDA), which is under active review by the US Food and Drug Administration (FDA). A target actin date (TDA) has been set by the regulators for insulin glargine application in June 2020.
The CEO of Biocon Biologics, Christiane Hamacher stated that with this, the company is closer to bring a more affordable insulin glargine for patients with diabetes in the US. Today, patients in parts of Europe, India, Australia, and other major emerging markets are already benefiting from it. Once Semglee get approved and commercialized, the product will expand access to this therapy.
Insulin Glargine by Biocon has already received regulatory approval in 70 countries and is commercialized in markets including Australia, Brazil, Japan, Mexico, and UAE.
Biocon and Mylan co-developed 11 biologic products; Insulin glargine is one among them. Mylan has exclusive commercialization rights for the product in the US, Canada, Europe, Australia, and New Zealand while Biocon has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.