According to the investigators, their data support the further development of CT-P16 as a bevacizumab biosimilar.
Biosimilar developer Celltrion last year announced that it was ready to begin a phase 3 study of its proposed bevacizumab biosimilar, CT-P16, an anti—vascular endothelial growth factor referencing Avastin. This month, researchers are reporting on a phase 1 study that showed equivalent pharmacokinetics (PK) between the proposed biosimilar and its EU- and US-licensed reference products.
In the double-blind, parallel-group trial, 144 healthy adult male volunteers were randomized to receive a single dose of CT-P16 (n = 47) at 5mg/kg, or the same dose of either EU-licensed (n = 49) or US-licensed (n = 48) reference bevacizumab.
The primary end points were area under the concentration—time curve (AUC) from time zero to infinity (AUC∞), AUC from time zero to the last quantifiable concentration (AUClast), and maximum serum concentration (Cmax).
PK equivalence was demonstrated if the 90% CIs of the geometric mean (GM) ratios of AUC∞, AUClast, and Cmax fell within the prespecified bioequivalence margin of 80% to 125%.
The investigators report that the 90% CIs for the GM ratios of all 3 end points fell within the prespecified bioequivalence margin, and the mean serum concentration—time profiles, secondary PK parameters, safety, and immunogenicity profiles were also comparable across all 3 groups.
According to the investigators, these data support the further development of CT-P16 as a bevacizumab biosimilar.
In addition to Celltrion, multiple biosimilar develoeprs are targeting bevacizumab, which is used to treat metastatic colorectal cancer, metastatic breast cancer, non—small cell lung cancer, and glioblastoma, and which is also increasingly used off-label to treat diseases of the eye, including diabetic retinopathy and age-related macular degeneration. TOT Biopharm, JHL Biotech, and Mylan have all disclosed clinical programs for proposed bevacizumab biosimilars; Amgen has seen both US and EU approval for its biosimilar, Mvasi, and Pfizer has received EU approval for its biosimilar, Zirabev. To date, no biosimilars for bevacizumab have been launched.
Reference
Cho SH, Han S, Ghim JL, et al. A randomized, double-blind trial comparing the pharmacokinetics of CT-P16, a candidate bevacizumab biosimilar, with its reference product in healthy adult males [published online March 9, 2019]. BioDrugs.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.