Alkem launches first cetuximab similar biologic in India

In May 2023, Alkem Oncology announced the launch of Cetuxa, the fist similar biologic of cetuximab used in the treatment of head and neck cancer. 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.

Cetuximab is an IgD1 (chimeric (mouse/human)) (mouse/human)) monoclonal antibody and epidermal growth factor receptor (EGFR) inhibitor used to treat metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer by blocking the activity of EGFR and preventing growth of cancer cells [1].

Cetuxa was approved by Directorate General of Goods and Services Tax Intelligence in India in January 2023 for the management of squamous cell cancers of head and neck. 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.

Head and neck cancer, which is primarily caused by the consumption of tobacco, is one of the most prevalent cancers in India, particularly among the lower income group. According to Global Cancer Observatory, it is estimated that there were 19.3 million incident cancer cases worldwide in 2020. India ranks third, accounting for around 15% of the global head and neck cancer disease burden, following China and the US.

Alkem Laboratories Managing Director Sandeep Singh stated, ‘In India, more than 76,000 patients are eligible for the use of cetuximab for the management of head and neck cancer. Currently, only around 1,611 patients are managed by this therapy. Its reach in India is limited partly due to its high cost. To address this issue, we have launched an affordable similar biologic, which is backed by indigenous research and production.’

A number of cetuximab biosimilars are being developed by other companies but none have reached approval stage at this point (June 2023) [2-5].

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that similar biologics approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of cetuximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-cetuximab
2. GaBI Online - Generics and Biosimilars Initiative. Mabpharm gains approval for infliximab biobetter in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 12]. Available from: www.gabionline.net/biosimilars/news/mabpharm-gains-approval-for-infliximab-biobetter-in-china
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 12]. Available from: www.gabionline.net/biosimilars/general/biosimilar-pipelines-for-south-korean-firms-celltrion-and-samsung-bioepis
4. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for cetuximab and infliximab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 12]. Available from: www.gabionline.net/biosimilars/research/Positive-phase-III-results-for-cetuximab-and-infliximab-copy-biologicals
5. GaBI Online - Generics and Biosimilars Initiative. Amgen and Simcere to collaborate on copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 12]. Available from: www.gabionline.net/pharma-news/Amgen-and-Simcere-to-collaborate-on-copy-biologicals-in-China

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