In December last year, the Drug Controller of India approved the world’s first biosimilar versions of Roche’s metastatic breast cancer drug Herceptin (trastuzumab). However, ex parte proceedings by Roche at the Delhi High Court last week has led to an injunction stopping Mylan’s Hertraz and Biocon’s Canmab from being compared to its branded drug Herceptin.
The injunction (found here) restricts either drug from referring to Herceptin, in “data relating to its manufacturing process, safety, efficacy and sales, in any press releases, public announcements, promotional or other material for the defendants' drugs.”
In an official statement sent to Biopharma-Reporter.com from Mylan said the two firms “were given no notice of these proceedings, nor were they given an opportunity to be heard in this matter.”
However, Mylan pointed out “the Judge expressly refused to enjoin the marketing authorization received by Biocon and Mylan for Canmab and Hertraz,” and whilst there are limitations on using trademarks and data, the drugs can still be marketed.
“We do not believe that the injunction will prevent us from manufacturing and selling Hertraz,” the company said, “and we look forward to providing access to a more affordable, high quality treatment option to the thousands of women in India suffering from metastatic breast cancer.”
Mylan did not respond to further questions as to whether Hertraz would be sold as a rival biologic to Herceptin, rather than a biosimilar, and we also did not receive responses from the Central Drugs Standard Control Organisation (CDSCO) of India as to whether there was a precedent for such a situation.
The injunction will stand until the next date of the hearing on February 28.
Roche’s defense
Biocon did not say whether it was to push through with the launch of Canmab, as expected this month, but did tell us the development was “extremely shocking, but not unexpected,” following the decision by Roche not to pursue the Indian patent for Herceptin in August.
“This proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab.”
However, Roche spokesperson Claudia Schmitt told Biopharma-Reporter.com the firm had taken the action to ensure the safety and efficacy of the drugs, as bioequivalents of Herceptin.
“As the holder of the Herceptin trademark we have a duty to ensure that if a company claims its product is a biosimilar of or similar to our innovator product trastuzumab, that this really is the case.”
Though she said the Indian regulators had approved the two biologics as trastuzumab, as per their regulatory process, Roche was seeking clarity as to whether they met the criteria for biosimilar products.
“This is particularly important in the case of Biocon and Mylan’s products, as there is very limited information in the public domain and we believe it is important to ensure that patients and physicians can make informed decisions.”
A biosimilar to Herceptin manufactured by Celltrion has also recently been approved in South Korea, however Schmitt told us its actions in this case was related to the specific situation in India.
Biosimilar Guidelines
The injunction is also facing criticism from the Campaign on Affordable Trastuzumab - a patient and public interest group who last month issued a statement condemning Biocon and Mylan for the proposed price of their Herceptin biosimilars – who has called for an urgent re-appraisal of the biosimilar guidelines in India.
“The action of the court in giving an interim ex-parte injunction in a case where access to a life-saving drug is at stake is unwarranted and inexplicable,” the group said in a statement.
“Significantly, Roche was a member of the drafting committee for the biosimilar guidelines, which have been invoked in this plea. This move by Roche bears out our contention that the guidelines are weighted against innovators in developing countries, and are likely to be used by big pharma to protect its own interests”