Campaign for Affordable Trastuzumab demands review of biosimilar guidelines

The Campaign for Affordable Trastuzumab, a platform working in the health sector to make trastuzumab affordable, has demanded to the union health ministry an urgent re-appraisal of the biosimilar guidelines in the wake of the Delhi High Court order dated February 5, 2014 in which the court has granted stay on the marketing of a biosimilar of the breast cancer drug trastuzumab.

“The Campaign for Affordable Trastuzumab demands an urgent re-appraisal of the biosimilar guidelines. The guidelines must be geared to encouraging innovation, fostering competition and lowering prices, rather than to enable originators to protect their monopolies and reap unethical profits,” said Kalyani Menon-Sen, coordinator of the Campaign, which was launched in November 2012 and endorsed by over 200 Indian and global patient associations, cancer survivors, health movements, women’s rights activists and eminent jurists. The Campaign has since been demanding that the government of India intervene to enable the production of biosimilars and ensure that the drug is made available to all those who can benefit from it.

Deploring the ex parte order of the Delhi High Court on a petition by Swiss pharma major Roche, granting stay on the marketing of a biosimilar of the breast cancer drug trastuzumab, the Campaign said that it seems that the order has been issued with little concern for the Supreme Court guideline on ex-parte injunctions. Since getting such injunctions vacated or cleared is a time-consuming and complicated process, the SC has laid down that interim injunctions or stay orders should be granted only after hearing the defendants/respondents.

Even in exceptional cases where ex-parte injunctions are granted, the SC guidelines direct the court to record in the order that if the suit is eventually dismissed, the plaintiff or the petitioner will have to pay full restitution, actual or realistic costs and profits. Both these directions have been ignored in the present order, it said.

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.

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, the Campaign said.