Researchers Report Positive Early Data for Cetuximab Biosimilar

The Center for Biosimilars Staff

Cetuximab (Erbitux), an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody used in the treatment of head and neck and colorectal cancer, so far faces no biosimilar challengers. However, Chinese researchers are reporting positive preclinical results for a proposed biosimilar, APZ001.

Cetuximab (Erbitux), an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody used in the treatment of head and neck and colorectal cancer, so far faces no biosimilar challengers. However, Chinese researchers are reporting positive preclinical results for a proposed biosimilar, APZ001.

Previous studies have demonstrated that APZ001 has the same therapeutic effects as the reference product in a mouse model, and a pharmacokinetic (PK) assessment in Cynomolgus monkeys showed that the 2 products have similar PK, toxicology, and immunogenicity.

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In the current study's observation of mouse behavior, both the reference and biosimilar showed negative effects in terms of nervous excitability, autonomic and nonautonomic nervous function, nervous-muscle function, and coordination function. There was no significant difference in negative behavior between mice given the 2 drugs, however.

In an evaluation of the 2 drugs in Cynomolgus monkeys, no significant differences were recorded in heart function, though monkeys given APZ001 showed insignificant differences in heart rate and blood pressure from those given the reference, under anesthesia. No differences were observed between breath parameters or electrocardiogram results.

There were also no significant differences observed in drug-related urinary volume alteration between monkeys administered the 2 drugs. During periods of drug administration and recovery in rabbits, no abnormal reactions were observed in animals receiving either product.

In human tissues, both APZ001 and the reference showed positive signals in endocardium, alveolar epithelial cells, and surrounding vessels, and showed negative results in kidney and liver tissues.

The investigators concluded that, in their safety assessment and bioequivalence study of the 2 products, APZ001 and the reference showed highly similar effects in the animal models, and no severe adverse events were observed in any of the tested animals. APZ001, they conclude, may be a viable biosimilar for cetuximab.

Reference

Wang X, Guo J, Deng X, et al. Comparative safety assessments of the biosimilar APZ001 and Erbitux in pre-clinical animal models. Acta Cir Bras. 2018;33(8): 690-702. doi: 10.1590/s0102-865020180080000005.