Europe drug regulator's panel gives thumbs-up to Biocon's insulin glargine

The CHMP positive opinion will be considered by the European Commission which is expected to decide on approval in April this year.

January 29, 2018 / 09:29 PM IST
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Biopharmaceutical firm Biocon and its partner Mylan on Monday announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of insulin glargine called Semglee, a long-acting insulin analog used in the treatment of diabetes in people aged 2 years and above.

The CHMP - the committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use - base its recommendation after comparing the 52 weeks data related to safety, efficacy and immunogenicity of Biocon-Mylan's version of insulin glargine with that of the reference product.

The CHMP positive opinion will be considered by the European Commission which is expected to decide on approval in April this year.

Biocon in its earnings call last week said it expects see insulin glargine to hit the European market by end of this year. The company has received GMP certificate from European drug regulator EMA for Malaysian insulins facility from where it plans to ship glargine to Europe.

“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," said Arun Chandavarkar, CEO and Joint Managing Director of  Biocon.


“With approximately 60 million people living with diabetes in the European Region and prevalence on the rise, we have an important role to play to help increase access to high-quality, more affordable treatment options for patients," said Mylan President Rajiv Malik.

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.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Jan 29, 2018 07:45 pm

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