Biocon gets Europe and Australia approval to sell insulin glargine

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26 Aug, 2025 12:21

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Biocon and its partner Mylan on Wednesday said their co-developed biosimilar insulin glargine has received marketing approvals in Europe and Australia.

Insulin glargine is a biosimilar version of Sanofi's top selling Lantus. Insulin glargine is a long acting insulin that removes patients from administering multiple injections in a day.

It's the first biosimilar from Biocon and Mylan’s joint portfolio to be approved in Europe. Earlier the duo got approval for breast cancer drug Trastuzumab in US.

"The marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency. Semglee 100 units/mL 3 mL pre-filled disposable pen for people with diabetes," Biocon Bolton and Mylan said in a joint statement.

The EC approval of Biocon-Mylan's insulin glargine applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

Additionally, the Therapeutic Goods Administration (TGA), Australia has also approved biosimilar insulin glargine Semglee 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia.

Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said, "The approval of  Mylan and Biocon’s biosimilar insulin glargine by the European Commission and TGA Australia are important milestones in our collaboration. It furthers our mission to provide a high quality, affordable insulin analog for people with diabetes globally. As a credible, global insulins player, we are committed to address the growing healthcare challenges associated with diabetes and have made significant investments in R&D and manufacturing to build scale and make our affordable insulins portfolio available in many markets.”