India Pharma Outlook Team | Tuesday, 23 September 2025
Alkem Laboratories announced the launch of Pertuza injection 420mg/14mL, a pertuzumab biosimilar that has been developed in India and can be used in HER2-positive breast cancer.
With this achievement, Alkem aims to provide better access to advanced cancer care by complementing the innovative drug with a biosimilar of a lower cost.
Pertuza has been developed by Alkem’s biotech subsidiary and has been studied as part of a pivotal phase 3 clinical trial, demonstrating equivalent efficacy, safety, and immunogenicity to the reference product. The launch helps to address a longstanding challenge in India regarding access to pertuzumab with treatment costs that have relegated many HER2-positive breast cancer patients to no available options.
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“Breast cancer is the most common cancer among Indian women, and addressing its growing burden requires treatments that are effective, accessible and affordable. Oncology is a priority area for Alkem, and our efforts are focused on developing treatment options that combine scientific excellence with wider access...therapy available to thousands of women each year who would otherwise be excluded,” said Dr Vikas Gupta, Chief Executive Officer, Alkem.
Alkem utilizes research-backed development, regulatory-compliant manufacturing, and a comprehensive oncology distribution network to position Pertuza as both scientifically backed and widely available. It also highlights the company's ongoing expansion in oncology, where it has existing biosimilars such as cetuximab, denosumab, bevacizumab, and romiplostim.
With Pertuza, Alkem's capacity to provide affordable biologics to Indian patients is further enhanced, helping to close accessibility gaps while adhering to international quality and safety standards. The launch of this pertuzumab biosimilar is poised to change the treatment landscape for HER2-positive breast cancer in India.