EMA Accepts Mylan’s Filing for Biosimilar of Sanofi’s Lantus Insulin Analog

Mylan and Biocon, a biopharmaceutical company headquarterd in Bangalore, India, report that the European Medicines Agency has accepted for review Mylan’s marketing authorization application for insulin glargine, a long-acting insulin analog used to treat adults with Type 2 diabetes and adults and pediatric patients (children 6 years and older) with Type 1 diabetes for the control of high blood sugar.

Lantus is Sanofi’s top-selling product, with 2015 sales of EUR 6.4 billion ($7.1 billion). Lantus is facing generic competition. In 2015, the FDA approved Eli Lilly and Company’s Basaglar (insulin glargine injection) 100 units/mL, a long-acting insulin with an identical amino acid sequence to Lantus. Per Lilly’s settlement agreement with Sanofi, Basaglar became e available in the US starting on December 15, 2016.

In September 2016, Sanofi filed a patent-infringement suit against Merck Sharp & Dohme Corp. in the US District Court for the District of Delaware alleging the infringement of 10 patents related to its insulin products, Lantus (insulin glargine) and Lantus Solostar. The suit was triggered by a notification received from Merck in early August 2016, in which Merck stated it had filed a new drug application (NDA) 505(b)2 with the US Food and Drug Administration for an insulin glargine drug product. Merck also stated that its NDA included a Paragraph IV certification challenging all of the 10 Sanofi patents listed in the FDA Orange Book for Sanofi’s Lantus and Lantus SoloStar products,

Mylan and Biocon have co-developed insulin glargine, The filing includes analytical, functional and preclinical data,as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan’s and Biocon’s Insulin glargine with Lantus. The PK study demonstrated PK and pharmacodynamic bioequivalence of Mylan’s and Biocon’s insulin glargine relative to that of the reference drug Lantus.

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 US, 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.

Source: Mylan

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