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Alkem launches Cetuxa

Cetuxa is the world’s first biosimilar of Cetuximab for head and neck cancer.
Levy

Alkem Oncology has launched Cetuxa, the world’s first biosimilar of Cetuximab used for the treatment of head and neck cancer.

Cetuxa has been researched and manufactured indigenously by Enzene Biosciences, the biological arm of Alkem Laboratories.

Cetuximab binds to the extracellular domain of the epidermal growth factor receptor, which is overexpressed in many human cancers, including head and neck cancer and colorectal cancer. This process prevents EGFR from binding with its endogenous ligand, blocking the receptor-dependent transduction pathway and providing many anti-tumor effects.

[Read more: AAM report: Generics, biosimilars generated $373B savings in 2021]

Cetuxa is administered as an intravenous infusion and is available as 100 mg (2 mg/ml) in a single dose vial. The initial dose is 400 mg/m2, with a follow-up of 250 mg/m2 per week. Cetuximab has a proven record in terms of better progression-free survival and overall survival compared to chemotherapy alone for the management of head and neck cancer, the company said.

“In India more than 76,000 patients are eligible for the use of cetuximab for the management of head and neck cancer. Currently, only 1,611 patients are managed by this therapy i.e., around 2% of eligible patients. Its reach in India is limited partly due to its high cost. To address this issue, we have launched an affordable biosimilar which is backed by indigenous research and production. We aim to ensure its availability in all parts of the country making it easily accessible to the Indian population,” said Sandeep Singh, managing director at Alkem Laboratories.

"We are glad to announce Cetuxa drug as it will be a historic breakthrough in terms of saving the lives of cancer patients. We have developed Cetuxa as a goal to make cancer therapy more accessible and affordable to millions of patients suffering from head and neck cancer," said Himanshu Gadgil, CEO at Enzene Biosciences.

[Read more: Sufficiently similar: What the FDA approval of the first interchangeable biosimilar product means for pharmacists]

Head and neck cancer is one of the most prevalent cancers in India which is primarily caused by the consumption of tobacco. Furthermore, as most patients are from low to middle socio-economic backgrounds, the launch of Cetuxa will help in making the treatment affordable and accessible to all patients, the company said.

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