Even as the Swiss pharma major Roche has recently decided to relinquish the patent for its breast-cancer drug Trastuzumab (Herceptin) in India, the Campaign for Affordable Trastuzumab, a platform working in the health sector to make Trastuzumab affordable, has urged the government to fast-track the approval for biosimilars of Trastuzumab. That can bring hope of a disease-free life for the thousands of Indian women who are battling HER2+ breast cancer.
Now that the patent barrier has been removed, the Campaign also urged the generic manufacturers to come forward immediately and apply for licenses to manufacture and market biosimilars of Trastuzumab.
“We call on the government to take all necessary measures to speed up the development of biosimilars of Trastuzumab. Development and clinical trial of biosimilars should be publicly funded, and fast-track processes put in place for regulatory approval, as well as for access to Trastuzumab through the public health system,” Campaign's spokeswoman Kalyani Menon Das said.
The patent for Trastuzumab in India was granted in violation of the provisions of the Indian Patent Act and stands on very shaky legal ground. A post-grant opposition to this patent has been pending with the Kolkata Patent Office for more than five years. Earlier this year, the Cancer Patients' Aid Association had also moved for the revocation of the Trastuzumab patent, Das said.
Official unresponsiveness to these communications has allowed Roche to misuse this frivolous patent to implement a predatory pricing policy and block generic entry for more than six years. The human costs are enormous - more than a million women have been diagnosed with HER2+ cancer in the six years when this patent has been in force, with less than 10 per cent of them able to access the drug, the Campaign's spokeswoman said.
Roche's decision to relinquish the Trastuzumab patent should not be mistaken for altruism – it is a face-saving gesture in response to the eroding legitimacy of both the patent and the pricing policy in India. It is also a tactical move to avoid compulsory licensing, which would have much more serious and far-reaching implications for its plans in the Indian market, she further said.
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.
The Campaign for Affordable Trastuzumab - initiated in November 2012 and endorsed by over 200 Indian and global patient associations, cancer survivors, health movements, women's rights activists and eminent jurists – has been working to highlight the lethal impact of Roche's predatory pricing policy on women with HER2+ breast cancer, and has been urging the government to allow production of biosimilars of Trastuzumab.