Plus   Neg

Mylan, Biocon Get Positive CHMP Opinion For Biosimilar Insulin Glargine Semglee

Mylan N.V. (MYL) and India-based Biocon Ltd. announced Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion recommending approval of Biosimilar insulin glargine Semglee.

Semglee is a long-acting insulin analog used in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected in April.

In addition to the European submission, marketing applications for Semglee have been submitted in Australia, Canada, and the U.S. and are planned for key Emerging Markets.

Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Glargine is one of the three insulin analogs being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for insulin glargine in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.

Arun Chandavarkar, CEO and Joint Managing Director, Biocon said, "CHMP's decision to recommend approval of Biocon and Mylan's biosimilar insulin glargine brings us a step closer to offer high quality, affordable options for people with diabetes in the EU."

For comments and feedback contact: editorial@rttnews.com

FDA/Panel Decisions

1 Articles
Follow RTT