
Alkem Laboratories Ltd. has officially announced the launch of Pertuza injection 420mg/14mL, an indigenously-developed and manufactured biosimilar of pertuzumab, in the Indian market. Pertuza is indicated for the treatment of HER2-positive breast cancer, a prevalent form of cancer among Indian women.
This launch is a strategic move by Alkem to address the significant challenge of accessibility and cost barriers that have prevented many HER2-positive breast cancer patients in India from receiving treatment with pertuzumab.
Key Highlights of the Launch
- Product: Pertuza injection 420mg/14mL (Pertuzumab Biosimilar).
- Indication: Treatment of HER2-positive breast cancer.
- Affordability: The launch aims to provide an affordable and accessible alternative to the reference product.
- Clinical Data: In a pivotal Phase 3 clinical trial, the biosimilar, developed by Alkem’s biotech subsidiary, demonstrated equivalence in efficacy, safety, and immunogenicity to the innovator’s reference product.
- Make in India: Pertuza is an indigenously-developed and manufactured product, reinforcing self-reliance in critical oncology care.
Dr. Vikas Gupta, Chief Executive Officer, Alkem, commented on the launch:
“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… 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.”
Strengthening the Oncology Portfolio
The introduction of Pertuza further solidifies Alkem’s commitment to the oncology segment. The company currently has a growing portfolio of oncology drugs, which includes other key biosimilars such as:
- Cetuximab biosimilar
- Denosumab biosimilar
- Bevacizumab biosimilar
- Romiplostim biosimilar
The launch of Pertuza is expected to ensure scientific credibility and improved patient access, backed by Alkem’s robust research, regulatory-compliant manufacturing, and strong oncology distribution network across the country.
