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.
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?
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
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.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.