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- || Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca, Centus Biotherap
Clinical, PK/PD data, Journal: Pharmacokinetics, safety, tolerability, and immunogenicity of FKB238, a new biosimilar of bevacizumab, in healthy participants. (Pubmed Central) - Jun 30, 2022
The study demonstrated the PK similarity of FKB238 to both EU-bevacizumab and US-bevacizumab after a single intravenous infusion. FKB238 was well tolerated in healthy participants, and there was no difference in ADA incidence among the 3 products.
- ||||||| Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca, Centus Biotherap
Trial completion, Metastases: Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Mar 10, 2022
P3, N=731, Completed, Sponsor: Centus Biotherapeutics Limited
FKB238 was well tolerated in healthy participants, and there was no difference in ADA incidence among the 3 products. Active, not recruiting --> Completed
- || Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca, Centus Biotherap
Review, Journal: FKB238: A Bevacizumab Biosimilar. (Pubmed Central) - Sep 2, 2021
FKB238 has similar physicochemical and pharmacodynamic properties to those of reference bevacizumab and pharmacokinetic similarity was shown in healthy volunteers and in patients with non-small cell lung cancer (NSCLC). FKB238 demonstrated equivalent clinical efficacy to reference bevacizumab in patients with advanced or recurrent nonsquamous NSCLC, with similar tolerability, safety and immunogenicity profiles.
- ||| Avastin (bevacizumab) / Roche
Clinical, P3 data, Journal: Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC). (Pubmed Central) - Jul 28, 2021
P3
Efficacy equivalence was demonstrated between the two drugs, and safety profiles were similar. There were no meaningful differences in efficacy and safety between FKB238 or bevacizumab in patients with non-sq-NSCLC.
- | Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca
#CentusBiotherapeutics Receives #EuropeanMarketing Authorization for #Equidacent®, Biosimilar #Avastin® https://t.co/VumLQV6Z4v (Twitter) - Sep 29, 2020
- paclitaxel / Generic mfg.
[VIRTUAL] Efficacy and safety of bevacizumab biosimilar FKB238 versus originator bevacizumab: Results from a phase III trial in patients with non-squamous non-small cell lung cancer (NS-NSCLC). () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5671;
P3
ORR efficacy equivalence was demonstrated, and the safety profiles of both drugs were similar. Research Funding: Centus Biotherapeutics Ltd
- ||||| Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca, Centus Biotherap
Trial completion date, Trial initiation date, Trial primary completion date, Metastases: Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Mar 14, 2019
P3, N=731, Active, not recruiting, Sponsor: Centus Biotherapeutics Limited
Research Funding: Centus Biotherapeutics Ltd Trial completion date: Jun 2019 --> Feb 2022 | Initiation date: Jun 2016 --> Sep 2016 | Trial primary completion date: Jun 2019 --> Jan 2019
- ||||| Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca, Centus Biotherap
Enrollment closed, Metastases: Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Feb 5, 2018
P3, N=731, Active, not recruiting, Sponsor: Centus Biotherapeutics Limited
Trial completion date: Jun 2019 --> Feb 2022 | Initiation date: Jun 2016 --> Sep 2016 | Trial primary completion date: Jun 2019 --> Jan 2019 Recruiting --> Active, not recruiting
- || Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca, Centus Biotherap
New P3 trial, Metastases: Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Jun 23, 2016
P3, N=730, Recruiting, Sponsor: Centus Biotherapeutics Limited