Roche has secured an injunction in India that prevents Biocon and partner Mylan from comparing their version of Herceptin to the Swiss major's branded blockbuster cancer drug.

A couple of weeks ago, Biocon announced that it would be launching a version of Herceptin (trastuzumab), to be called CANMab and Hertraz, for HER2-positive breast cancer, having been approved in November by the Drug Controller General of India (DCGI). It has been priced 25% lower than the branded treatment.

However the Swiss drugmaker has launched lawsuits against Biocon, Mylan and the DCGI and got the backing for an injunction from the Delhi High Court that the two generics groups cannot launch, supporting Roche's claim that the trials that led to Indian approval for CANMab do not meet the criteria for biosimilars approved in the country.

According to the Economic Times newspaper, Roche argues that there is no public record in the Indian clinical trial registry or elsewhere to show that Phase I and Phase II studies for the drug have been carried out.

Biocon responded by saying "it is an extremely shocking, but not unexpected development", claiming that the legal move "is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab". The Bangalore-based firm went on to say that CANMab and Hertraz "are world-class products that adhere to stringent quality standards and have been developed on the basis of applicable biosimilar guidelines".

Biocon concluded by noting that "we are confident that once we are heard by the court, this injunction placing certain limits on promotional activities will not stand".