Alkem Laboratories announced on Monday the launch of Pertuza, a biosimilar of pertuzumab, a targeted therapy used in the treatment of HER2-positive breast cancer.
Developed and manufactured indigenously, Alkem’s Pertuza is positioned as an affordable alternative to the innovator drug Perjeta, marketed by the Roche Group. In a pivotal late-stage clinical study, the biosimilar—developed by Alkem’s biotech arm—showed equivalent efficacy, safety, and immunogenicity compared to the reference product.
“Oncology is a priority area for Alkem, and our efforts are focused on developing treatment options that combine scientific excellence with wider access,” said Dr Vikas Gupta, chief executive officer, Alkem. He added, “Alkem aims to make this critical therapy available to thousands of women each year who would otherwise be excluded.”
A biosimilar is not an identical replica of the reference biologic, but a highly similar product that must demonstrate no clinically meaningful differences in safety, purity, or potency. Regulatory approval requires proof of similarity in mechanism of action, route of administration, dosage form, and strength.
Access to pertuzumab in India has remained limited due to high treatment costs, with only a small fraction of HER2-positive patients able to afford it. Alkem highlighted that biosimilars like Pertuza are designed to expand affordability and reach.
The company is not the only player in this space—Zydus has also developed a pertuzumab biosimilar, branded Sigrima, which is co-marketed with Dr. Reddy’s under the trade name Womab.
Looking ahead, Alkem is banking on its oncology portfolio and other growth levers to fuel expansion.