Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan
R Kuribayashi, K Goto, A Hariu… - Expert Opinion on …, 2024 - Taylor & Francis
ABSTRACT Background The 'Questions and Answers (Q&A)'document regarding Japanese
biosimilar guideline elucidated that Japanese participant enrollment in at least one …
biosimilar guideline elucidated that Japanese participant enrollment in at least one …
Clinical and regulatory considerations for the use of bevacizumab biosimilars in metastatic colorectal cancer
Biosimilars–biological medicines highly similar to a licensed reference product (RP)–can
mitigate the risk of drug shortages by providing treatment alternatives and, with their lower …
mitigate the risk of drug shortages by providing treatment alternatives and, with their lower …
[HTML][HTML] Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized …
T Chu, J Lu, M Bi, H Zhang, W Zhuang… - Cancer Biology & …, 2021 - ncbi.nlm.nih.gov
Objective: This phase 3 study aimed to test equivalence in efficacy and safety for QL1101, a
bevacizumab analogue in Chinese patients with untreated locally advanced non-squamous …
bevacizumab analogue in Chinese patients with untreated locally advanced non-squamous …
Candidate bevacizumab biosimilar CT-P16 versus European Union reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer: a …
C Verschraegen, Z Andric, F Moiseenko, T Makharadze… - BioDrugs, 2022 - Springer
Background CT-P16 is a candidate bevacizumab biosimilar. Objective This double-blind,
multicenter, parallel-group, phase III study aimed to establish equivalent efficacy between …
multicenter, parallel-group, phase III study aimed to establish equivalent efficacy between …
A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers
D Shin, YJ Lee, J Choi, D Lee, M Park… - Cancer chemotherapy and …, 2020 - Springer
Purpose To compare pharmacokinetics, safety, tolerability, and immunogenicity between
SB8, a bevacizumab biosimilar, and the European Union (EU) and United States (US) …
SB8, a bevacizumab biosimilar, and the European Union (EU) and United States (US) …
Mapping thematic trends and analysing hotspots concerning the use of stem cells for cartilage regeneration: a bibliometric analysis from 2010 to 2020
D Xia, J Wu, F Zhou, S Wang, Z Zhang… - Frontiers in …, 2022 - frontiersin.org
Background: Defects of articular cartilage represent a common condition that usually
progresses to osteoarthritis with pain and dysfunction of the joint. Current treatment …
progresses to osteoarthritis with pain and dysfunction of the joint. Current treatment …
[HTML][HTML] Safety of intravitreal injection of Stivant, a biosimilar to bevacizumab, in rabbit eyes
A Lashay, H Faghihi, A Mirshahi… - Journal of Ophthalmic …, 2020 - ncbi.nlm.nih.gov
Purpose To evaluate the safety of intravitreal injection of Stivant, a biosimilar to
bevacizumab, in rabbits using electrophysiological and histological analysis. Methods Both …
bevacizumab, in rabbits using electrophysiological and histological analysis. Methods Both …
Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies
Stupendous elevation in the healthcare costs has followed with the inception of the current
unconventional options of treatment available for cancer patients. There is a dire need of …
unconventional options of treatment available for cancer patients. There is a dire need of …
A phase I, randomized, single-dose study evaluating the biosimilarity of TAB008 to bevacizumab in healthy volunteers
J Wang, L Qi, L Liu, Z Wang, G Chen, Y Wang… - Frontiers in …, 2019 - frontiersin.org
Objective: This study compared the pharmacokinetics (PK), safety, and immunogenicity of
the biosimilar TAB008 monoclonal antibody to bevacizumab (Avastin®) in normal healthy …
the biosimilar TAB008 monoclonal antibody to bevacizumab (Avastin®) in normal healthy …
A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the …
X Zhu, H Qian, J Sun, M Wu, C Yu, Y Ding… - Cancer Chemotherapy …, 2021 - Springer
Purpose To compare the pharmacokinetic profiles, safety and immunogenicity of proposed
bevacizumab biosimilar HLX04 with reference bevacizumab in healthy Chinese males …
bevacizumab biosimilar HLX04 with reference bevacizumab in healthy Chinese males …