Roche surprised everyone when it dropped its patent application for Herceptin in India last year rather than be at risk of surrendering a compusory license in that market. It seemed to be surprised itself when two months later Biocon and Mylan announced they would be launching biosimilar versions, CanMab and Hertraz respectively, of Herceptin in February of 2014. Roche has recovered by filing suits to stop the launch.
In its suit, Roche has charged that Biocon and Mylan did not do any clinical phase I or II trials to support their drugs claim of being biosimilar versions of Herceptin. They say there is no public record of these trials. They further sued the Drug Controller General of India (DCGI) for allowing a launch to proceed. Roche charges that neith company has followed India's guidelines for biosimilars, and the DCGI approved Bicon's trial designs even before guidelines were in place. They say that the drug regulators approval for biosimilars couldn't have come about so soon. Roche emphasizes that its suit is not a patent challenge, nor a challenge to the drugs approval. It is a challenge that the drugs are marketing themselves as biosimilar versions of Herceptin and Roche feels that this hasn't been properly established under India's biosimilar guidelines.
Herceptin sold more than $6 B in 2013. It has sales of only $21 M in India however as patient advocates claim that it is too expensive for the market. Roche did allow Emcure Pharmaceuticals to produce a licensed biosimilar for 15% lower sales price. Biocon and Mylan say they will market their drugs at a list price that is 25% less than Roche's. Roche is clearly trying to protect its IP and maket share. They appear to have been surprised by India's rapid approval of a biosimilar once its patent application was dropped. Roche is now trying to use the other legal avenues at its disposal to block the introduction of these "biosimilar" versions of Herceptin -- saying that they did not get approved by playing under existing rules.
The New Dehli High Court agrees to the point that is has issued an injunction blocking Bicon's and Mylan's launches until a hearing can take place later this month. This will be one to watch. The case shows to me that governments/countries will actively look to get biosimilars on the market to reduce healthcare costs, and that the regulatory environment for biosimilar approvals will need to be worked out over time through the courts as the innovators seek to protect their IP investment and market share from premature erosion. See FiercePharma, The Economic Times, and FirstWordPharma.
Posted by Bruce Lehr Feb 7th 2014.