Biocon, Mylan to challenge Delhi HC interim order on breast cancer drug

Hyderabad: Biocon Ltd and its partner Mylan NV on Wednesday said they are going to challenge the Delhi high court interim order that put certain limitations on marketing of their version of breast cancer drug Trastuzumab.

“It’s an interim order, obviously we will be appealing this order,” said Kiran Mazumdar-Shaw, chairperson and managing director of Biocon, in post-results media interaction.

“This is really an issue about regulatory understanding. I think the regulators need to address the regulatory aspects,” Mazumdar-Shaw said.

Biocon said the order does not have material impact on the company, as it was not prevented from selling the product.

Mylan NV on Wednesday said it has filed an appeal against the interim order of Delhi high court that put restrictions on its version of breast cancer drug Trastuzumab.

“We are aware that the order places certain limitations with respect to packaging and labelling, but intend to challenge those limitations. We have filed an appeal,” the Mylan spokesperson was quoted by BusinessLine.

In its interim order on 25 April, the Delhi high court allowed sale and manufacture of Trastuzumab by Biocon and Mylan with certain restrictions.

Justice Manmohan Singh, in a 227-page interim order, said that Biocon can continue to sell and manufacture the drug, without calling their product “biosimilar” and/ or “biosimilar to Herceptin, Herclon and Biceltis”, or in any way ascribing any bio-similarity with that of the Roche products in any press releases, public announcements, promotional or in printed form, and from relying upon or referring the plaintiffs’ names.

A biosimilar product is a complex biological product that follows a different approval pathway compared to chemical drugs. Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

Roche’s subsidiary Genentech Inc. is the innovator of monoclonal antibody trastuzumab, which is used primarily in the treatment of HER 2 positive breast cancer.

Roche and its licensed partners market Trastuzumab in India under brand names such as Herceptin, Herclon and Biceltis. The patents of Herceptin lapsed in India in May 2013.

The court was also critical about the role of Indian regulator Drug Controller General of India (DCGI) for approving Biocon’s version of Trastuzumab without applying the 2012 Guidelines on Similar Biologics and exempting the company from phase-1 and 2 clinical trials.

Roche Products (India) Pvt. Ltd, the Indian unit of Swiss pharmaceutical company F. Hoffmann-La Roche AG, has filed a suit before Delhi high court, seeking an injunction on marketing and sale of Trastuzumab by Biocon and Mylan, representing the drug as biosimilar until appropriate tests and studies are conducted following guidelines on similar biologics and from issuing press releases and relying upon or referring to the trademark claiming similarity with Roche’s trastuzumab.

Biocon and Mylan market ‘CANMAb’ and ‘HERTRAZ’ as biosimilars of Herceptin in India. In 2009, Biocon partnered with Mylan to develop five complex biosimilar products, including biosimilar Trastuzumab.

Biocon launched CANMAb in 2014, and sells at 25% cheaper rates than innovator Roche’s Herceptin at ₹ 75,000 per 440mg.