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.
Click to read more about cetuximab.
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.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share
October 11th 2024Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.
Duke Publishes Recommendations for Developing CGT Biosimilars
October 9th 2024Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.