Roche gets temporary court injunction on Herceptin biosimilar in India

Citing safety and quality concerns, Swiss-based Roche ($RHBBY) has won a temporary injunction from the Delhi High Court to block the expected launch of a biosimilar of breast cancer drug Herceptin (trastuzumab) by Reliance Life Sciences, the Economic Times reports.

The newspaper said that an 8-page order noted "serious issues are raised" in granting a block any launch, adding that Roche contends issues related to quality are at stake if testing protocols are skipped. A Nov. 16 date was set for submissions on the case by both parties.

Roche India Associate Director for Corporate Communications Shilpika Das confirmed the court case in an email to FiercePharmaAsia.

Roche's trastuzumab (currently marketed in India as Herclon) has been shown to help women with early stage HER2 positive breast cancer from developing into an advanced, incurable disease, Das said in the email.

"We have sought an injunction against the launch of Reliance's purported biosimilar of trastuzumab and the Delhi High Court has temporarily restrained Reliance from launching the product. We took this action because we are genuinely concerned whether the company's product is as safe and efficacious as our innovator product trastuzumab."

Reliance Life Sciences has reportedly recently obtained package insert approval for its biosimilar version named TrastuRel, along with another Indian firm, Zydus Cadila, for its Vivitra version of trastuzumab, a step that usually proceeds a formal launch.

Zydus or Reliance did not respond to requests for comment.

Reports earlier this year suggested the Indian government has mulled a compulsory license on trastuzumab, one of several biosimilars that firms such as Bangalore-based Biocon, Hyderabad-based Dr. Reddy's ($RDY) and Cipla, among others, have launched or are developing for the local and emerging markets.

In the case of trastuzumab, Mylan ($MYL) and Biocon are currently battling Roche in the Delhi High Court over a launch last year in India of a biosimilar with a judgment possible by the end of the year.

- here's the story from the Economic Times