Indian biopharmaceutical company Biocon in collaboration with pharmaceutical firm Mylan has launched an insulin glargine biosimilar, dubbed Semglee in Australia, under the Pharmaceutical Benefits Scheme (PBS).

Biocon said that the Semglee is an insulin glargine solution for injection 100IU/mL in a 3mL pre-filled pen, and marks the first insulin glargine biosimilar.

Biocon Biologics CEO Christiane Hamacher said: “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.

“As a leading global insulins player, Biocon has been addressing the needs of patients with diabetes for over 15 years and we are confident that 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.”

Semglee insulin glargine has been approved by TGA

Insulin glargine is a long-acting basal insulin analogue, 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. It is administered once daily to control the blood sugar levels in diabetes patients.

According to the biopharmaceutical company, diabetes is the world’s fastest-growing chronic condition and became the biggest challenge for the health system in Australia. Approximately two million people in Australian have diabetes, developing diabetes at a rate of 280 people every day, and one person every five minutes.

Biosimilars are considered as more affordable treatment options and help to manage the costs of the health care system in Australia. Biosimilars have been used safely and effectively in Europe, US, Australia and many other countries.

The new Insulin Biosimilar Semglee has been co-developed by Biocon and Mylan based on clinical study data that demonstrated positive results for Semglee, with no clinically meaningful differences in efficacy, safety, purity and potency, with the reference insulin glargine.

Semglee insulin glargine biosimilar is currently approved in more than 40 countries across the world.

Mylan Australia country manager Sylvain Vigneault said: “The launch of Semglee further demonstrates Mylan’s ongoing commitment to increase access to biosimilars for patients. Biosimilars mark a new era in treatment. They enable more patients to be treated, deliver significant savings to the PBS and help provide sustainability to the healthcare system overall.

“We are delighted that Semglee enables Mylan to strengthen and support its global diabetes and metabolism portfolio of approximately 400 products.”