Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 3 November 2016 that the regulatory submission for their proposed insulin glargine biosimilar had been accepted for review by the European Medicines Agency (EMA).
Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.
The product is a proposed biosimilar to Sanofi’s Lantus (insulin glargine), which had net worldwide sales of US$6.4 billion in 2015. The patents on Lantus expired in 2014 in both Europe and the US [1].
Mylan and Biocon have co-developed the insulin glargine biosimilar and it marks their third biosimilar filing to be accepted by EMA in 2016. Their proposed pegfilgrastim (MYL-1401H) and trastuzumab (Myl-1401O) biosimilars regulatory submissions were accepted for review by EMA in July 2016 [2] and August 2016 [3], respectively.
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogues [4]. The proposed insulin glargine biosimilar is one of the three insulin analogues being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for insulin glargine in the US, Canada, Australia, New Zealand, the European Union and European Free Trade Association countries.
Biocon has already received approval for its insulin glargine similar biologic in India (Basalog) and glargine biosimilar (insulin glargine biosimilar 2) in Japan [5, 6]. Biocon has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-EMA
4. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to parter on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products
5. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
6. GaBI Online - Generics and Biosimilars Initiative. Biocon receives Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2] Available from: www.gabionline.net/Biosimilars/News/Biocon-receives-Japanese-approval-for-insulin-glargine-biosimilar
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