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Alkem launches pertuzumab biosimilar in India for treatment of breast cancer

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, the company said in a press release.

September 22, 2025 / 18:56 IST
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Alkem Laboratories Ltd. on Monday 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, the company said in a press release.

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 said it 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," said ,” said Dr. Vikas Gupta, Chief Executive Officer, Alkem.
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Oncology is a priority area for Alkem, and our efforts are focused on developing treatment options that combine scientific excellence with wider access," Gupta added.

Alkem said it aims to make this critical therapy available to thousands of women each year who would otherwise be excluded

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

Viswanath Pilla
Viswanath Pilla is a business journalist with 16 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Sep 22, 2025 06:56 pm

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