Zydus and Roche in legal battle over biosimilar amid rising breast cancer cases in India

GlobalData underscores the urgent need for affordable biosimilars to meet the demands of a growing number of HER2+ breast cancer patients

The ongoing legal battle between Zydus Life Sciences and Roche, against the backdrop of increasing HER2+ breast cancer cases in India, underscores the urgent need for affordable biosimilars to provide wider access to life-saving treatments, according to GlobalData, a leading data and analytics company.

Zydus and Roche have been at odds since the former tried to create a biosimilar to pertuzumab, an antibody targeting the human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

Zydus’s biosimilar, Sigrima, is modeled after Roche’s Perjeta (pertuzumab) and targets the HER2+ breast cancer market in India.

Roche first filed a complaint with the Drugs Controller General of India (DCGI), alleging that Zydus might have used an unauthorized supply chain to procure the reference drug for clinical trials and then for a formulation patent infringement

However, Roche does not hold a product patent for pertuzumab in India. Zydus’ Sigrima received approval from the Central Drugs Standard Control Organization (CDSCO) in April 2024 and was permitted for sale in June 2024.

GlobalData’s Pharmaceutical Intelligence Center projects that the number of five-year diagnosed prevalent cases of HER2+ breast cancer in India will grow at an annual rate of 2.43%, increasing from 114,393 in 2024 to 139,486 in 2033.

India ranks second in annual growth rate among major markets, surpassed only by China.

Jithendra Kancharla, Pharma Analyst at GlobalData, highlighted that breast cancer is the most prevalent cancer among women in India, with HER2+ cases accounting for nearly 15-20% of these diagnoses.

Current treatments include antibodies targeting HER2, such as trastuzumab and pertuzumab, often used in combination with chemotherapeutic agents.

Kancharla explained: “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.”

The analytics company pointed out the high cost of exclusive HER2+ breast cancer treatments as a significant barrier.

Roche’s therapies, including Herclon (Trastuzumab), Kadcyla (trastuzumab emtansine), Perjeta (pertuzumab), and Phesgo (pertuzumab + trastuzumab + hyaluronidase), are priced between $730 and $6,396 in India.

In contrast, biosimilars offered by local pharmaceutical companies, including Zydus, are marketed at prices 30-70% lower than their branded counterparts.

For instance, Zydus markets Vivitra, a biosimilar for Herclon, at 41% less than the innovator drug, and Ujvira, a biosimilar for Kadcyla, at 70% less.

Kancharla noted that the battle against breast cancer in India is a multifaceted challenge requiring 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,” he said.

Given the high cost of exclusive targeted therapies, he emphasised the urgent need for inexpensive substitutes, such as biosimilars.

He added that by adopting biosimilars, India can meet the needs of a larger number of breast cancer patients requiring treatment.