The European committee's positive opinion will be considered by the European Commission and the regulator's decision on approval of insulin glargine injection is expected in April, Biocon and Mylan said in a joint statement
Mumbai: Biocon Ltd and Mylan N.V. said on Monday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommended approval of insulin glargine injection, co-developed by the companies, for diabetes treatment.
The CHMP’s positive opinion will be considered by the European Commission and the regulator’s decision on approval of this product, to be sold under the name Semglee, is expected in April, the companies said in a joint press release.
As part of the marketing authorization application to the EU regulator, the companies had submitted requisite data to show similarity of its insulin glargine to the reference product, Lantus, of Sanofi.
“This (CHMP’s recommendation) is an outcome of our commitment to be a credible, global insulins player on the back of significant investments together with our partner Mylan in global scale manufacturing and R&D (research and development) after having previously obtained approvals for our insulin glargine in Japan and key emerging markets," Arun Chandavarkar, chief executive officer and joint managing director of Biocon, said.
About 60 million people are estimated to have been living with diabetes in the European region.
Apart from EU, the companies have filed marketing applications for insulin glargine in Australia, Canada, and the US.
“Once Biocon-Mylan gets the approval, it will be the third player after Merck-Samsung (2017) and Eli Lilly-BI (2016) in the insulin glargine market in Europe. Next in line are pegfilgrastim and trastuzumab approvals in Europe which should come in second half of 2018," Edelweiss Securities said in a note.
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 the companies.
Mylan has exclusive commercialization rights for insulin glargine in the US, Canada, Australia, New Zealand, the European Union and European Free Trade Association countries, while Biocon has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.
On Monday, shares of Biocon ended up 1.23% at Rs614.80 on the BSE, while benchmark Sensex index closed up 0.65% at 36,283.25 points.
