The product will be sold in a pre-filled disposable pen and is the first biosimilar from Biocon and Mylan to be cleared in Europe.
Semglee will launch in Australia later this year, Mylan reported, and in various markets across Europe. The companies have also submitted marketing applications for Semglee in Canada and the U.S.
“We are excited to be able to bring Mylan and Biocon’sbiosimilar insulin glargine to Europe and Australia where millions of people are currently living with diabetes, and we are committed to continuing to bring high quality, more affordable biosimilar products to markets around the world,” Mylan president Rajiv Malik said in prepared remarks.
“The approval of Mylan and Biocon’s biosimilar insulin glargine by the European Commission and TGA Australia are important milestones in our collaboration. It furthers our mission to provide a high quality, affordable insulin analog for people with diabetes globally,” Biocon CEO & joint managing director Dr. Arun Chandavarkar added.
Mylan and Biocon have exclusive deals covering three insulin analogs, including Semglee. Mylan holds exclusive commercialization rights for insulin glargine in the U.S., Canada, Australia, New Zealand, the E.U. and European Free Trade Association countries, while Biocon has exclusive rights in Japan and some emerging markets.