Delhi High Court puts restrictions on Biocon and Mylan breast cancer drug marketing

The Delhi High Court has allowed Biocon and Mylan to continue manufacturing and marketing their breast cancer drug under the brand names Canmab and Hertraz. Roche is the importer and marketer of innovator molecule trastuzumab, a biological drug used primarily for treatment of HER 2 positive breast cancer, in India.

Roche had filed a petition seeking an injunction alleging that there was an imminent threat of introduction of purported biosimilar version of its biological drug Trastuzumab, which was claimed to have been jointly developed by Biocon and Mylan under their brand names Canmab and Hertraz. Roche’s subsidiary Genentech is the innovator of monoclonal antibody Trastuzumab. Roche and its licensed partners market Trastuzumab in India under brand names such as Herceptin, Herclon and Biceltis. The Herceptin patents lapsed in India in May 2013.

While passing the order on the Roche petition, the Court said that a biosimilar, a medical product almost identical to an original product manufactured by a different firm, would need to follow stringent guidelines framed in 2012 for getting regulatory approvals. A Roche spokesperson said that the ruling sends a strong, positive signal that the development, manufacture and approval of biosimilars in India must be subject to rigorous clinical and regulatory standards as per the applicable law.

The Court allowed the sale and manufacture of affordable cancer drugs by Biocon and Mylan with certain restrictions on packaging and labelling and regulatory process. Justice Manmohan Singh of the Delhi High Court made it clear that these companies would not call their product 'biosimilar' to Herceptin, Herclon, Biceltis, the brand names of products by Roche Products (India) Pvt Ltd.

Though both the defendants were allowed to manufacture and market the drug by qualifying the INN name trastuzumab, the Court also held that they could not use the said name on the carton or package insert as a brand name. Biocon and its partner Mylan said they were going to challenge the Delhi high court interim order that put certain limitations on marketing of their version of breast cancer drug trastuzumab.

Biocon said its product portfolio would not be affected by the Court order. 'The High Court judgement does not restrict the sale and manufacture of Biocon's Trastuzumab, which is in the interest of patients...the current judgement will not affect our product portfolio,' a Biocon spokesperson said.