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Alkem launches Pertuza, a pertuzumab biosimilar, in India for treatment of HER2-positive breast cancer

 


·       Alkem aims to expand access to treatment with its affordable pertuzumab biosimilar that meets global standards and is backed by trusted science

Mumbai, September 22, 2025: Alkem Laboratories Ltd. (BSE: 539523, NSE: ALKEM, “Alkem” and its subsidiaries) today announced the launch of Pertuza injection 420mg/14mL, a pertuzumab biosimilar, in India for the treatment of HER2-positive breast cancer.   

Alkem’s Pertuza is an affordable, indigenously-developed and manufactured biosimilar of pertuzumab. In the pivotal phase 3 clinical trial, Alkem’s pertuzumab biosimilar, developed by its biotech subsidiary, demonstrated equivalence in efficacy, safety, and immunogenicity to the reference product of the innovator. 

Accessibility of pertuzumab in India has remained a significant challenge and only limited HER2-postive breast cancer patients are able to use it in their treatment due to cost barriers. By bringing an affordable pertuzumab biosimilar, backed by research, regulatory-compliant manufacturing, and strong oncology distribution network, Alkem strives to ensure scientific credibility and improved accessibility.

 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. The launch of Pertuza reflects this commitment and further strengthens our oncology portfolio. Alkem aims to make this critical therapy available to thousands of women each year who would otherwise be excluded,” said Dr. Vikas Gupta, Chief Executive Officer, Alkem.

Alkem has a growing portfolio of oncology drugs with key products being cetuximab biosimilar, denosumab biosimilar, bevacizumab biosimilar, and romiplostim biosimilar, among others.

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