Alkem Labs launches world’s first biosimilar of Cetuximab for head & neck cancer treatment

29 May 2023 | News

Cetuxa is administered as an intravenous infusion and is available as 100 mg (2 mg/mL) in a single-dose vial

image credit- shutterstock

image credit- shutterstock

Alkem Oncology has announced the launch of 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 Limited, the biological arm of Alkem Laboratories.

Head and neck cancers (HNCs) are one of the most common cancers worldwide and in India too. According to the Global Cancer Observatory (GLOBOCAN) estimates, there were 19.3 million incident cancer cases worldwide in 2020 and India ranked third after China and the United States of America.

Overall, 57.5% of global head and neck cancer cases occur in Asia and India accounts for 30% of these cases. Annually, in India, the prevalence of head and neck cancer is approximately 5,00,000 cases with over 1,25,000 deaths.

Cetuxa aims to increase the accessibility and affordability of a novel cancer drug for head and neck cancer patients. It is a biosimilar of cetuximab, a monoclonal antibody, and received Drugs Controller General of India (DCGI) approval on 16th January 2023 for this indication.

Cetuximab binds to the extracellular domain of the epidermal growth factor receptor (EGFR), 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-tumour effects. 

Cetuxa is administered as an intravenous infusion and is available as 100 mg (2 mg/mL) in a single-dose vial. Initial dose is 400 mg/m2, follow-up of 250 mg/m2 per week. 



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