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.
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 per cent 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, states, “Breast cancer is the most prevalent cancer among women in India. HER2+ cases account for nearly 15-20 per cent 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 unauthorised 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 Organisation (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 per cent below the innovator drugs. Zydus markets biosimilars for Herclon- Vivitra (marketed at 41 per cent cheaper than innovator) and Kadcyla- Ujvira (marketed at 70 per cent cheaper than the innovator).
“The battle against breast cancer in India is a multifaceted challenge that requires the collective efforts of multinational and local pharmaceutical companies. Both have pivotal roles in driving innovation, improving accessibility, and raising awareness, improving the quality of care for patients across the country, and ultimately saving lives. The necessity for inexpensive substitutes, such as biosimilars, is urgent given the high price of exclusive targeted therapies. India can address the demands of a greater number of breast cancer patients who require therapy by adopting biosimilars,” concludes Kancharla.
*Major markets include Australia, Canada, China, France, Germany, India, Italy, Japan, South Korea, Spain, the UK, and the US.