November 26, 2013 | By Márcio Barra
A biosimilar version of Roche’s blockbuster breast cancer drug from Mylan and Biocon was approved today in India, following the Indian Kolkata Patent Office denial of Roche’s patent on the grounds that it hadn’t been properly submitted.
India’s Biocon announced today it received approval from India’s regulatory authorities to market a generic version of Herceptin. This biosimilar was co-developed alongside Mylan, which will share revenue on the drug with Biocon. In case the drug ends up being approved in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries, Mylan will have exclusive marketing rights.
Biocon will market their Herceptin Biosimilar in India under the brand name CANMAb, while Mylan will market the drug as Hertraz elsewhere in the world. The drug is expected to be available early next year in India.
The development and release of CANMab was prompted by a decision issued by the Kolkata Patent Office in August, denying Roche’s patent, saying that it hadn’t been properly submitted. Roche said it wouldn’t pursue a patent in India for Herceptin, removing the biggest potential obstacles for Indian drug makers to start selling generic versions of a drug that, otherwise, had a patent that was valid to 2019. In an attempt to protect its property rights, Roche partnered up with domestic drugmaker Emcure Pharmaceuticals to produce the a generic version of the drug in India, and the pair said they would roll out a less costly version of Herceptin. Roche also cut Herceptin prices in India by 31% to $1,366 per month to make it more affordable.
Roche didn’t comment on the Indian approval of the biosimilar to Herceptin.