Biocon, Mylan get European Commission nod to market biosimilar insulin glargine

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26 Aug, 2025 12:21

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Biotechnology major Biocon and Mylan today said their co-developed biosimilar insulin glargine has received marketing authorisation approval from the European Commission (EC).

Semglee 100 units/mL 3 mL prefilled disposable pen for people with diabetes, is the first biosimilar from Biocon and Mylan's joint portfolio to be approved in Europe, the companies said in a statement.

The Therapeutic Goods Administration (TGA) Australia has also approved the biosimilar product for people with diabetes in Australia, it added.

"We are excited to be able to bring Mylan and Biocon's biosimilar insulin glargine to Europe and Australia where millions of people are currently living with diabetes..., Mylan President Rajiv Malik said.

The EC approval of Semglee applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein, the statement said.

"The approval of Mylan and Biocon's biosimilar insulin glargine by the European Commission and TGA Australia are important milestones in our collaboration," Biocon CEO and Joint MD Arun Chandavarkar said.

In addition to these approvals, marketing applications for Semglee have also been submitted in Canada and the US. Several submissions are planned for key emerging markets, the statement said.