INDIA – Enzene Biosciences Limited, the biological arm of Alkem Laboratories, has officially launched a biosimilar version of Roche’s Avastin in the Indian market.
The originator product, Roche’s Avastin, was approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for the treatment of metastatic colorectal cancer.
This development comes as the number of pharmaceutical companies developing biosimilar products and copy biologicals has increased rapidly in the past years.
In the wake of these advances, the Generics and Biosimilars Initiative (GaBI) was founded in 2008 by Pro Pharma Communications International.
The mission of GaBI is to foster the worldwide efficient use of high-quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable, and sustainable health care.
According to the Generics and Biosimilars Initiative, EMA and FDA regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as well as for originator biological.
The World Health Organization has promoted the biosimilarity paradigm for the provision of safe and effective products and provided considerable support to the WHO Member States to improve regulatory convergence.
Consequently, Enzene Biosciences has introduced its first-of-its-kind Bevacizumab to serve as an alternative to Avastin, which is a highly-expensive biologic.
The launch of the Avastin biosimilar product is in line with Enzene Biosciences’ goal of increasing the accessibility, availability, and affordability of cancer drugs in India.
Bevacizumab is a humanized monoclonal antibody that inhibits the formation of new blood vessels in tumors by blocking the action of vascular endothelial growth factor A (VEGF-A).
“Bevacizumab is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney, and ovarian. It is also used ‘off-label’ to treat some eye diseases,” GaBI reports.
Unsurprisingly, Enzene Biosciences has begun manufacturing its novel Avastin biosimilar product as a way to bring new therapeutic options for patients with multiple cancer types.
Alekm’s Bevacizumab is a human monoclonal antibody that slows the growth of new blood vessels in tumors and will be used to treat patients suffering from metastatic colorectal cancer.
It aligns with the company’s mission to deliver innovative and affordable biomanufacturing for novel biologics and biosimilars globally.
Comparably, Alkem Oncology launched Cetuxa, the first similar biologic of cetuximab used in the treatment of head and neck cancer, in India earlier this year.
The cetuximab originator was developed by Merck and is sold under the brand name Erbitux.
“Alkem’s Cetuxa has been researched and manufactured in India by Enzene Biosciences Limited, the biological arm of Alkem Laboratories,” states publicly available data published by the Generics and Biosimilars Initiative.
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