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A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin® (EU and US) in healthy male subjects.
Wynne, Chris; Schwabe, Christian; Batra, Sonica Sachdeva; Lopez-Lazaro, Luis; Kankanwadi, Suresh.
Afiliação
  • Wynne C; Christchurch Clinical Studies Trust Ltd., 31 Tuam Street, Post Office Box 2856, Christchurch, 8011, New Zealand.
  • Schwabe C; Auckland Clinical Studies Ltd., ACS House, 3 Ferncroft Street, Grafton, New Zealand.
  • Batra SS; Biologics, Dr. Reddy's Lab. Ltd., Survey No. 47, Bachupally, Medchal Malkajgiri District,, Telangana, Hyderabad, 500 090, India.
  • Lopez-Lazaro L; Biologics, Dr. Reddy's Lab. SA, Elisabethenanlage 11, Basel, 4051, Switzerland.
  • Kankanwadi S; Biologics, Dr. Reddy's Lab. SA, Elisabethenanlage 11, Basel, 4051, Switzerland.
Br J Clin Pharmacol ; 84(10): 2352-2364, 2018 10.
Article em En | MEDLINE | ID: mdl-29943831
AIM: The aim of this study was to compare the pharmacokinetics (PK) of DRL_BZ with that of EU-approved (reference medicinal product; RMP) and US-licensed (reference product; RP) bevacizumab (Avastin® ) in healthy male subjects. METHODS: In this double-blind, parallel-group, Phase 1 study (BZ-01-001), men aged 20-45 years were randomized 1:1:1 to receive a single intravenous infusion of 1 mg kg-1 of bevacizumab as DRL_BZ, RMP or RP. A total of 149 subjects were randomized (DRL_BZ, 50; RMP, 50; RP, 49). Primary endpoints included maximum observed serum concentration (Cmax ), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity (AUC(0-∞) ), and area under the concentration-time curve from time zero (pre-dose) to last quantifiable concentration (AUC(0-t) ). Secondary objectives were to compare the safety and immunogenicity of DRL_BZ with those of the reference products. RESULTS: Primary PK parameters were comparable across groups, and 90% confidence intervals for the geometric mean ratios of the primary PK endpoints were within the pre-specified equivalence margins (80-125%) for all pairwise comparisons (DRL_BZ vs. RMP, DRL_BZ vs. RP and RMP vs. RP). No deaths or serious adverse events were reported. Similar numbers of subjects reported similar numbers of treatment-emergent adverse events in the three treatment groups. One subject who received DRL_BZ had anti-drug antibodies at the Day 85 visit; however, no anti-drug antibodies were detected in this subject at the 12-month follow-up visit. CONCLUSIONS: PK, safety and immunogenicity of DRL_BZ were comparable to EU-approved and US-licensed bevacizumab in healthy male subjects.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares / Bevacizumab / Antineoplásicos Imunológicos Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies Limite: Adult / Humans / Male Idioma: En Revista: Br J Clin Pharmacol Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Nova Zelândia

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares / Bevacizumab / Antineoplásicos Imunológicos Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies Limite: Adult / Humans / Male Idioma: En Revista: Br J Clin Pharmacol Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Nova Zelândia