Alkem Laboratories has announced the launch of Pertuza injection 420mg/14mL, a pertuzumab biosimilar, in India for the treatment of HER2-positive breast cancer. The launch represents a significant step toward addressing accessibility challenges for this critical oncology therapy in the Indian market.
Clinical Development and Regulatory Approval
Alkem's Pertuza is an affordable, indigenously developed and manufactured biosimilar of pertuzumab, developed by the company's biotech subsidiary Enzene Biosciences. In the pivotal phase 3 clinical trial, Alkem's pertuzumab biosimilar demonstrated equivalence in efficacy, safety, and immunogenicity to the reference product of the innovator.
The biosimilar targets the HER2 (Herceptin) protein and binds it to inhibit its pairing with other proteins that help send growth signals, which slows down or stops the cancer cells from growing.
Addressing Market Access Challenges
Accessibility of pertuzumab in India has remained a significant challenge, with only limited HER2-positive breast cancer patients able to use it in their treatment due to cost barriers. The reference product, Perjeta (Pertuzumab) marketed by Genentech, a Roche subsidiary, generated net worldwide sales of over 3.6 billion Swiss francs (nearly Rs 38,500 crore) according to Roche's 2024 financial results.
"Breast cancer is the most common cancer among Indian women, and addressing its growing burden requires treatments that are effective, accessible and affordable," said Dr. Vikas Gupta, Chief Executive Officer of Alkem. "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."
Strategic Impact and Market Position
By bringing an affordable pertuzumab biosimilar backed by research, regulatory-compliant manufacturing, and a strong oncology distribution network, Alkem strives to ensure scientific credibility and improved accessibility. The company aims to make this critical therapy available to thousands of women each year who would otherwise be excluded from treatment.
Alkem has a growing portfolio of oncology drugs with key products including cetuximab biosimilar, denosumab biosimilar, bevacizumab biosimilar, and romiplostim biosimilar, among others.
Competitive Landscape
Before Alkem's launch, Zydus Lifesciences had obtained conditional approval for its pertuzumab biosimilar brand 'Sigrima' in India. However, the brand became involved in a legal dispute with the innovator when Roche sued Zydus alleging infringement of the patent protection period. In October 2024, a Division Bench of Delhi High Court restrained the Indian drugmaker from marketing the therapy. In its injunction plea, the Swiss drug giant had raised concerns over the quality and safety of the biosimilar brands of its innovative therapy.
