Alkem Oncology has launched Cetuxa, a biosimilar version of Cetuximab used in the treatment of head and neck cancer. Cetuximab is a Merck drug sold under the brandname Erbitux.

Alkem’s Cetuxa has been researched and manufactured indigenously by Enzene Biosciences Limited, the biological arm of Alkem Laboratories. An Alkem representative told businessline that the biosimilar is priced at ₹9,990 for a vial. This stands compared to multiple doses of the original, at different price points, from ₹16,000-plus to almost ₹1 lakh, according to industry data.

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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, the company said. Cetuxa received regulatory approval in India mid-January this year.

Sandeep Singh, Managing Director at Alkem Laboratories, 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 ie, around 2 per cent 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 that 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.”

“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,” the note explained.

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Head and neck cancers are among the most common cancers worldwide, including in India. According to the Global Cancer Observatory (GLOBOCAN) estimates, there were 19.3 million cancer cases worldwide in 2020, with India ranking third after China and the US. Overall, 57.5 percent of global head and neck cancer cases occur in Asia and India accounts for 30 per cent of these cases, the company said. Annually, in India, the prevalence of head and neck cancer is approximately 5,00,000 cases with over 1,25,000 deaths, it added.