Cetuximab biosimilar is under clinical development by Alkem Laboratories and currently in Phase III for Oral Cavity (Mouth) Cancer. According to GlobalData, Phase III drugs for Oral Cavity (Mouth) Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Cetuximab biosimilar LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Cetuximab biosimilar overview

Cetuximab biosimilar is a chimeric monoclonal IgG1 antibody that acts as an anti-neoplastic agent. It is formulated as solution for intravenous route of administration. Cetuximab is indicated for the treatment of head and neck cancer, particularly Squamous Cell Carcinoma of the Head and Neck (SCCHN) for patients with recurrent locoregional or metastatic conditions.
Cetuximab biosimilar (enz-124) is under development for the treatment of metastatic colorectal cancer, head and neck cancer, locoregional solid malignancies, head and neck cancer squamous cell carcinoma, malignant neoplasm of overlapping sites of lip, oral cavity and pharynx. It is administered intravenously. Cetuximab is a recombinant, chimeric monoclonal antibody. It acts by targeting epidermal growth factor (EGFR). The drug candidate is developed based on proprietary vector expression technology.

Alkem Laboratories overview

Alkem Laboratories (Alkem) is a pharmaceutical company that develops, manufactures and markets generic and specialty pharmaceutical products. The company’s product portfolio includes active pharmaceutical ingredients, generic products, branded products and nutraceuticals. Alkem provides drugs for acute and chronic diseases such as central nervous system disorders, gastro-intestinal infections, metabolic disorders and diabetes, cancer, skin and hair diseases, urologic diseases, cardiovascular diseases, immune disorders and pain relief. It also offers vitamins, minerals and nutrition products. The company distributes its products directly through its subsidiaries or through a wide network of distributors over more than 50 countries. It also exports products to Germany, Australia, South-East Asia, the US, the UK, Russia-CIS, and Africa. Alkem is headquartered in Mumbai, Maharashtra, India.

For a complete picture of Cetuximab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.