Tag Archive for biosimilars of Trastuzumab

Roche India gives up patent for breast cancer drug

Breast cancer drugs

A victorious Campaign for Affordable Trastuzumab calls for generic manufacturers to come forward and apply for licences to manufacture biosimilars of Trastuzumab so as to provide affordable medicines for women who are battling HER2+ breast cancer

By Team FI

The Campaign for Affordable Trastuzumab came to fruition on 15 August, 2013, when the Swiss pharmaceutical company Roche declared that it is relinquishing the patent for its breast-cancer drug Trastuzumab in India. The announcement was welcomed by the Campaign which was initiated in November 2012 and endorsed by several Indian and global patient associations, cancer survivors, health movements, women’s rights activists and eminent jurists.

A press release from the Campaign stated that this decision, “…brings hope of a disease-free life for the thousands of Indian women who are battling HER2+ breast cancer.” The campaign had been working to bring awareness of the Roche’s “predatory pricing policy on women with HER2+ breast cancer,” and urged the Indian government to allow production of biosimilars of Trastuzumab. The press release stated that its research into the issue has “uncovered serious anomalies and irregularities in the Indian patent, which appears to have been granted in violation of Sections 3(d) and 3(e) of the Indian Patent Act and is therefore unlikely to survive a legal challenge. Our inquiries also reveal a consistent pattern of bureaucratic manoeuvres to delay and deflect legal challenges to the Roche patent.”

Earlier this year an Expert Committee set up by the Health Ministry had recommended for compulsory licensing for Trastuzumab. The Campaign opined that, “…the decision to relinquish the patent on Trastuzumab is a tactical move by Roche to avoid compulsory licensing, which would have much more serious and far-reaching implications for its plans in the Indian market. Roche is already questioning the approval given to Dr Reddy’s Laboratories for the production of a biosimilar version of the lymphoma drug Rituximab, which will pose stiff competition to Roche’s MabThera. Roche is also planning to launch successors to Trastuzumab in the US and European markets before 2014, when biosimilars can be expected to enter the market.”

The Campaign urges generic manufacturers in India to come forward immediately and apply for licenses to manufacture and market biosimilars of Trastuzumab. The Campaign also urges the government to ensure a fast-track process for regulatory approval of biosimilars, and make Trastuzumab available through the public health system.