Biocon, Mylan launch insulin glargine biosimilar in Australia

Bio-technology major Biocon and pharmaceutical firm Mylan N V on Thursday announced the launch of insulin glargine biosimilar Semglee, indicated for the treatment of diabetes, in Australia.

Semglee is the first insulin glargine biosimilar available on the Pharmaceutical Benefits Scheme (PBS) in Australia, the companies said in a joint statement.

"We are extremely excited to enable affordable access to Semglee, a high quality biosimilar Insulin Glargine, co-developed and manufactured by Biocon Biologics, to people with diabetes in Australia. We are committed to use our science, scale and expertise to shift the access paradigm for patients in need of insulins across the globe," Biocon Biologics CEO Christiane Hamacher said.

Insulin glargine 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, the statement said.

"... availability of Semglee through the Pharmaceutical Benefits Scheme will expand patient access to this therapy in Australia and will reduce the cost burden for PBS," she added.

The PBS is part of the Australian Government's broader National Medicines Policy. Under the scheme, the government subsidises the cost of medicine for most medical conditions.

Australian regulator, Therapeutic Goods Administration (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, the statement said.

Mylan and Biocon's insulin glargine biosimilar is currently approved in more than 40 countries around the world, it added.

"The launch of Semglee further demonstrates Mylan's ongoing commitment to increase access to biosimilars for patients," Mylan Australia Country Manager Sylvain Vigneault said.

Shares of Biocon Ltd were trading 3.69 per cent higher at Rs 230.35 apiece on the BSE.