Biocon/Mylan launch first insulin glargine biosimilar in Australia

Biosimilars/News | Posted 11/10/2019 post-comment0 Post your comment

India-based biologicals specialist Biocon and US-based partner Mylan announced on 3 October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS).

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Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) approved Biocon/Mylan’s insulin glargine biosimilar, Semglee, in March 2018 [1]. TGA’s approval of Semglee was based on robust data that demonstrated that Semglee is highly similar to the reference insulin glargine, with no clinically meaningful differences in efficacy, safety, purity and potency. The biosimilar will be available as a solution for injection 100 IU/mL in a 3 mL pre-filled pen. 

Almost two million Australians have diabetes, with 280 Australians developing diabetes every day – one person every five minutes. The total annual cost impact of diabetes in Australia is estimated at AU$14.6 billion [2].

Australia has made significant efforts to create a competitive and sustainable biosimilars market. The Australian Government committed to the Biosimilar Awareness Initiative in 2015 and more recently provided the Generic and Biosimilar Medicines Association with AU$5 million in funding to promote the use of biosimilars.

Mylan and Biocon’s insulin glargine biosimilar is currently approved in more than 40 countries around the world.

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Biosimilars of insulin glargine

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 11]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Mylan launches first trastuzumab biosimilar in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 11]. Available from:

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Source: Biocon

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