Alkem Laboratories has introduced Pertuza (420 mg/14 mL), an indigenously developed pertuzumab biosimilar, in India for treating HER2-positive breast cancer. The drug is intended to provide a more affordable alternative to the innovator product while maintaining its clinical benefits.
Clinical trials conducted by Alkem’s biosimilars arm, Enzene Biosciences, showed that the biosimilar matched the reference pertuzumab product in efficacy, safety, and immunogenicity. This means that in head-to-head comparisons, Pertuza performed similarly in slowing tumour growth, had comparable side effects, and triggered immune responses similar to the original drug.
Affordability and access are central to Alkem’s strategy. Experts say that even though pertuzumab (sold globally under the brand name Perjeta by Roche) has improved outcomes for many patients, its high cost has put it out of reach for large segments of the Indian population. The launch of Pertuza is seen as a step toward reducing that gap.
Dr Vikas Gupta, Chief Executive Officer of Alkem, expressed that oncology is a priority area for the company. He said that Alkem is committed to combining scientific excellence with wider access. He added that Pertuza aims to bring this critical therapy to thousands of women each year who would otherwise be excluded from treatment because of cost barriers.
Experts believe that the launch of Pertuza could help in several ways. It could ease pressure on patients’ finances, potentially improve the adoption of HER2-targeted therapy across private and public hospitals, and reduce dependence on imports of expensive biologics. Since patent and pricing issues have often delayed entry of biosimilars in India, Pertuza’s approval shows progress in regulatory pathways and domestic manufacturing capabilities.
There is some competition: earlier, Zydus Lifesciences had won conditional approval for a pertuzumab biosimilar called “Sigrima”, but its launch was delayed because of legal challenges from Roche concerning patent protection. That case underscored both the regulatory and intellectual property hurdles that biosimilars face.
In the broader context of cancer care, India has a large and growing burden of breast cancer, and particularly of HER2-positive cases, which are more aggressive and require costly targeted therapy. Making treatments like pertuzumab more affordable could lead to earlier treatment, improved survival rates, and better quality of life for patients who otherwise might skip or delay therapy. Experts believe that innovation in biosimilars is key to scaling up access in oncology in India.
Overall, Pertuza’s launch is being viewed as a positive development — both from a medical standpoint and a policy perspective — in terms of driving down costs, enhancing local R&D and production, and widening access to vital cancer therapies.