Two Indian drug companies, Alkem and Lupin, will now market the first biosimilar version of Cetuximab, indicated for head and neck cancer, for under ₹10,000 a vial.

Cetuximab is a Merck drug sold under the brandname Erbitux. Alkem Oncology said recently it had launched its biosimilar version of Cetuximab under the brandname, Cetuxa.

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

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, with follow-up of 250 mg/m2 per week, said the company. Cetuxa received regulatory approval in India mid-January this year.

In a separate development, Lupin inked a strategic collaboration with Enzene Biosciences to launch Cetuximab in India. Lupin’s Lupitux is priced at ₹9,990 for a 100 mg vial, said a company representative.

“This collaboration marks a significant milestone in expanding therapeutic options and fostering innovation in the critical area of treatment of head and neck cancer. Cetuximab has received approval from the Drug Controller General of India (DCGI) for its effectiveness in treating head and neck cancer, particularly Squamous Cell Carcinoma of the Head and Neck (SCCHN), making it a crucial solution for patients with recurrent locoregional or metastatic conditions,” Lupin said.

Ensure availability

Sandeep Singh, Alkem Laboratories Managing Director, said: “In India, more than 76,000 patients are eligible for the use of cetuximab for the management of head and neck cancer. At present, only 1,611 patients are managed by this therapy — 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, 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.”

Head and neck cancers are among the most common cancers worldwide, including India. And, 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 United States of America.

Overall, 57.5 per cent 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.