Dive Brief:
- Roche is attempting to block the entry of copies of its major cancer drug Avastin in India, suing India’s Drug Controller General and generics maker Hetero Drugs in Delhi High Court, the Economic Times reports.
- The lawsuit reportedly alleges India’s regulators are not properly following the process for approval of biosimilars.
- Avastin, which is used to treat a range of cancers, brought in nearly $7 billion in sales last year, making it an important source of revenue for Roche. Generic drugmakers like Hetero, along with Intas Pharma and Reliance Life Sciences, aim to win some of Avastin’s market share in India.
Dive Insight:
In India, a company's application for a drug approval must be considered by three tiers of regulatory authorities—starting with the Subject Expert Committee, followed by a Technical Committee, and finally the high-level Apex Committee.
Roche alleges this process has been subverted for Avastin. This latest legal challenge follows close on the heels of a recent Delhi High Court ruling favoring Roche in a similar battle over its breast cancer drug Herceptin.
That ruling said Biocon and Mylan, two other generics makers, could not call their copies of Herceptin “biosimilars,” although it allowed both companies to continue marketing the drugs under revised labels, FiercePharma notes. Under the terms outlined in the ruling, the companies would not be able to include any clinical data from Roche on Herceptin in their product inserts.
In the case of Avastin, the Subject Expert Committee recommended approval for both Hetero Drugs and Intas’ copies in an April 7 review.
Pharma companies have repeatedly clashed with India’s government over intellectual property issues, and have taken steps to limit the threat from India’s strong generics industry.
Patient advocates and humanitarian groups, however, have argued lower cost drugs are necessary for public health. Cancer treatment is a major challenge for India, where there are one million new diagnoses of cancer each year, and a high level of associated mortality.
