Zydus and Roche legal battle highlights need for affordable breast cancer treatments in India
Zydus Life Sciences is engaged in a legal battle with Roche over its biosimilar, Sigrima, which is based on Roche’s Perjeta (Pertuzumab), targeting the human epidermal growth factor receptor 2-positive (HER2+) breast cancer market in India. As cases of HER2+ breast cancer rise in the country, the conflict underscores the critical need for cost-effective biosimilars to provide broader access to life-saving treatments, says GlobalData, a leading data and analytics company.
According to GlobalData’s Pharmaceutical Intelligence Center, the number of five-year diagnosed prevalent cases of HER2+ breast cancer in India is expected to increase at an annual growth rate (AGR) of 2.43% from 114,393 in 2024 to 139,486 in 2033. India has the second highest AGR among the major markets*, next only to China.
Jithendra Kancharla, Pharma Analyst at GlobalData, comments: “Breast cancer is the most prevalent cancer among women in India. HER2+ cases account for nearly 15-20% of breast cancer cases. The available treatments are antibodies targeting HER2, like trastuzumab and pertuzumab, and combinations of these with different chemotherapeutic agents. Pertuzumab, when used in combination with trastuzumab and a chemotherapeutic agent, provides a synergistic effect and clinical results show better progression-free survival and overall survival rates compared to these therapies used alone.”
Zydus and Roche have been at odds since the former tried to create a biosimilar to pertuzumab. Earlier, Roche lodged a complaint to the Drugs Controller General of India (DGCI), alleging Zydus might have procured the reference drug from an unauthorized supply chain to conduct the clinical trials and now for a formulation patent infringement. However, Roche does not currently hold a product patent for pertuzumab in India. It is a fact that Zydus’ Sigrima was approved by the Central Drugs Standard Control Organization (CDSCO) in April 2024 and permitted for sale in June 2024.
The exclusive therapies to treat HER2+ breast cancer command exorbitant prices. Roche’s Herclon (Trastuzumab); Kadcyla (trastuzumab emtansine); Perjeta (pertuzumab) and Phesgo (pertuzumab + trastuzumab + hyaluronidase) are available in India in a price range of $730 to $6,396.
At the same time, biosimilars for some of these therapies are marketed by a handful of local pharma companies at a price 30-70% below the innovator drugs. Zydus markets biosimilars for Herclon- Vivitra (marketed at 41% cheaper than innovator) and Kadcyla- Ujvira (marketed at 70% cheaper than the innovator).
