New Delhi: The Delhi high court on Thursday allowed Biocon Ltd and its partner Mylan Pharmaceuticals Pvt. Ltd to continue marketing their breast cancer drug Trastuzumab until 10 May.

Justices Badar Durrez Ahmed and Sanjeev Sachdeva delivered the ruling in response to an appeal by Biocon and Mylan against an interim order restricting them from marketing the drug, an innovation of Roche Holding AG’s unit Genentech Inc.

The judges said the case would be taken up on 10 May. Until then, the drug makers would be free to market Trastuzumab as before.

Biocon and Mylan cited various irregularities and contradictions in the order passed by justice Manmohan Singh on 25 April that imposed the restrictions.

“The order has imposed certain conditions on packaging and on use of Roche’s data in our product insert for the drug. Presently, there is no government policy on data exclusivity in India." senior advocate Prathiba Singh, appearing for Biocon, told the court.

The order was passed on the basis of a complaint which was later amended, the court was told. Another irregularity brought to the notice of the court was the deletion of the government as a party to the case.

“How can the government of India be deleted as a party when the final question of approval has to be decided by them?" senior advocate C.S. Vaidyanathan asked on behalf of Biocon.

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 a “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 form of communication.

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 on Herceptin lapsed in India in May 2013.

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 a biosimilar until appropriate tests and studies are conducted.

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 Trastuzumab.

“The division bench has refused to stay the order today and has ordered that the status prevailing prior to 25 April 2016 will continue to operate. Despite today’s developments, the situation for patients and physicians remains unchanged as there is still no evidence that these products have met the requirements of the biosimilar framework or any other regulatory pathway in India. The safety of patients will always remain a priority for Roche and we will continue to challenge companies that fail to present the data outlined in the Indian biosimilar framework. We have taken this action because as the holder of the Herceptin trademark and the innovator of Trastuzumab, we have a duty to ensure that if a company claims its product is a biosimilar of, or similar to our innovator product Trastuzumab, then it actually satisfies the criteria for a biosimilar," Roche said.

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