Biocon, Mylan launch first insulin glargine biosimilar, Semglee in Australia

Biocon Ltd and Mylan N.V. announced the launch of Semglee (insulin glargine solution for injection 100 IU/mL in a 3mL pre-filled pen), the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS).

Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar levels of those with diabetes. It is indicated for the treatment of type 1 diabetes mellitus in adults, adolescents and children aged six years and above and type 2 diabetes mellitus in adults. Diabetes is recognised as the world’s fastest growing chronic condition and is the biggest challenge confronting Australia’s health system.

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

TGA approval of Semglee, co-developed by Biocon and Mylan, 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.