First approved biosimilar from Biocon and Mylan’s joint portfolio in Europe

Additionally, the Therapeutic Goods Administration (TGA), Australia has also approved biosimilar insulin glargine Semglee 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia.

Mylan President Rajiv Malik noted that the companies can now bring biosimilar products to the markets of Europe and Australia, which are homes to millions of people with diabetes. “The investments that we have made to develop and manufacture a leading portfolio of complex products, including Semglee, is one way that we are delivering on our commitment to expand access to high quality medicine,” Malik said.

Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: “As a credible, global insulins player, we are committed to address the growing healthcare challenges associated with diabetes and have made significant investments in R&D and manufacturing to build scale and make our affordable insulins portfolio available in many markets.”

Diabetes is the fastest growing chronic condition in the world and the prevalence of this disease is increasing among all ages. In Europe the number of diabetics are expected to grow to 38 million by 2030, while in Australia it currently affects nearly two million people, companies said in press release.

Mylan plans to launch Semglee in Australia later this year and expects to begin launching the product across various markets in Europe in the second half of 2018.

In addition to these approvals, Mylan and Biocon have submitted marketing applications for Semglee in Canada and the U.S., which are also planned for key Emerging Markets, the companies said.

Image: Illustration