Mylan-Biocon Combine’s Generic Insulin May Hit Market Sooner
MYL-1501D, the biosimilar insulin being developed by US generic major Mylan and India’s Biocon, may hit the market earlier than expected as its trial data has already shown impressive results, allowing a faster approval process. The product, insulin glargin, which is a generic version of Sanofi’s human insulin brand Lantus, is currently awaiting regulatory approval in Europe and the filing is soon expected in the US and other markets.
A Biocon spokesperson said the company otherwise expects the launch by financial year 2018, depending on the approval.
Insulin glargin is 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.
The companies had on Sunday jointly presented new data from the insulin glargine clinical program at the American Diabetes Association’s 77th Scientific Sessions in San Diego. The presentation showed that trials have so far confirmed the efficacy, safety and immunogenicity of insulin glargine, in comparison to Lantus in patients with Type 1 and Type 2 diabetes. Data demonstrating pharmacokinetic and pharmacodynamic equivalence were also presented Sunday (11 June).
Biocon shares in the Indian market rose at least 1.25 per cent on Monday as investors reacted positively on the impressive trial results of insulin glargine that the company hopes to launch in the market soon. The stock closed at Rs 1035.20 a unit on BSE on Monday (12 June), while the benchmark Sensex was 166.36 points down at 31095.70.
Mylan and Biocon had last year said that the European Medicines Agency (EMA) accepted Mylan's Marketing Authorization Application (MAA) for insulin glargine for review. The companies, which have co-developed insulin glargine, look forward to offering a cheaper insulin treatment option for diabetic patients, who often find management of the disease expensive with no cheaper generics available in the market.
This filing at the EMA included analytical, functional and pre-clinical data, as well as results from the pharmacokinetics and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing it with Lantus.
It was in 2013 that Mylan and Biocon entered into a definitive agreement for an exclusive strategic collaboration on the development and commercialization of generic versions of three insulin analog products. Under the terms of that collaboration, Mylan will have the rights to develop and market Biocon's Glargine (the generic version of Sanofi's Lantus), Lispro (the generic version of Eli Lilly and Company's Humalog) and Aspart (the generic version of Novo Nordisk's NovoLog).
Both the companies also will share development, capital and certain other costs to bring the products to market, as per the agreement. While, Mylan will have exclusive commercialization rights in the US, Canada, Australia, New Zealand, the European Union and the European Free Trade Association countries through a profit-share arrangement with Biocon. Mylan will also have co-exclusive commercialization rights with Biocon in certain other markets around the world.
According to market data worldwide net sales of these three insulins (Lantus, Humalog and NovoLog) for 2012 were approximately $11.5 billion.
Mylan President Rajiv Malik had on Sunday (11 June) said in media statement that the companies are pleased with the positive results of the INSTRIDE clinical program, which demonstrate comparable clinical efficacy and safety of our insulin glargine to Lantus.
“We have long been deeply committed to supporting this community and advancing treatment for patients as the leading producer of oral diabetes medications in the US, and now we are continuing to deliver on our mission through our insulin programs.” Malik added in the statement.
According to Mylan, there’s a clear unmet need for more-affordable treatment options for diabetes patients with more than 29 million Americans living with diabetes at present and the cost of insulin products have been on the rise.
“This (the positive trial results) is an important milestone in our development of a more affordable insulin glargine and furthers our mission of enabling access by addressing the needs of diabetes patients globally,” said Arun Chandavarkar, CEO and Joint Managing Director, Biocon.
