The proposed biosimilar, TAB008, under development by TOT Biopharm, was compared with the reference bevacizumab in a randomized, double-blind, single-dose study conducted in 99 healthy adult males.
During the American Society of Clinical Oncology’s Annual Meeting, held June 1-5 in Chicago, Illinois, researchers presented results from a phase 1, randomized study that sought to evaluate the pharmacokinetic (PK) equivalence of a potential bevacizumab biosimilar with the originator product.
The proposed biosimilar, TAB008, under development by TOT Biopharm, was compared with the reference bevacizumab in a randomized, double-blind, single-dose study conducted in 99 healthy adult males.
Study participants were aged 18 to 45 years and were randomized to receive 1 mg/kg of TAB008 (n = 49) or reference bevacizumab (n = 50) over a 90-minute infusion. Participants were followed for 99 days post-infusion.
The study had 3 primary endpoints: area under the serum concentration—time curve from time 0 to time of last quantifiable concentration (AUC0-t), AUC from time 0 extrapolated to infinity (AUC0-∞), and the maximum observed serum concentration (Cmax). In addition, the study also evaluated the safety and immunogenicity of the potential biosimilar compared with the originator as secondary endpoints.
The treatment-group ratios of least squares geometric means for the 3 primary pharmacokinetic parameters were fully contained within the prespecified bioequivalence limits of 80% to 125% (90% CI, 103.66%-118.33% for Cmax; 94.32%-111.72% for AUC0-t; and 94.69%-112.23% for AUC0-∞).
Treatment-emergent adverse events (TEAEs) were reported in 25 participants (51%) in the TAB008 group and 22 (44%) subjects in the reference bevacizumab group. Drug-related TEAEs were reported in 19 (38%) of subjects in both groups.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3 TEAEs were demonstrated in 1 (2%) participant in the TAB008 arm, and 3 (6%) participants in the reference bevacizumab arm. However, no adverse events led to an individual’s discontinuation of participation in the study. In addition, the authors noted that no study participant developed binding or neutralizing anti-drug antibodies to the proposed biosimilar.
Researchers found that the proposed biosimilar demonstrated pharmacokinetic similarity to the reference product, and the safety and tolerability of the 2 products were also comparable.
Reference
Liu J, Wang X, Wang J, et al. A phase 1, randomized, single-dose study evaluating the pharmacokinetic equivalence of TAB008 and bevacizumab in healthy volunteers. J Clin Oncol. 2018;36(suppl; Abstract e14504).
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.