RT Journal Article
T1 Clinical and Regulatory Considerations for the Use of Bevacizumab Biosimilars in Metastatic Colorectal Cancer.
A1 Taïeb, Julien
A1 Aranda, Enrique
A1 Raouf, Sherif
A1 Dunn, Helen
A1 Arnold, Dirk
K1 Drug approval
K1 Extrapolation
K1 Gastrointestinal cancer
K1 MVASI
K1 Sensitive population
AB 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 costs, increase patient access to medication and reduce health care expenditure. However, limited knowledge of biosimilar approval processes and lack of confidence in their quality and efficacy can limit their uptake. Importantly, biosimilars are approved based on tightly controlled regulatory pathways to demonstrate that the physical, chemical, and biological properties of the proposed biosimilar are highly similar to the RP, with no clinically meaningful differences. Initially, a battery of highly sensitive in vitro studies are performed, comparing critical quality attributes between the proposed biosimilar and RP. Subsequently, in vivo pharmacodynamic studies compare the activity and physiologic effects of the biosimilar and RP. Finally, clinical studies are conducted, including a pharmacokinetic equivalence study and a confirmatory comparative clinical trial. The latter is performed in the most sensitive patient population for which the RP is licensed, to provide the greatest possibility of identifying any clinically meaningful differences between the proposed biosimilar and RP. When equivalent safety and efficacy have been demonstrated in one setting, the totality of evidence, together with scientific justification that there are no anticipated differences between the RP and proposed biosimilar in mechanism of action, pharmacokinetics, immunogenicity or toxicity, allows extrapolation into indications where clinical studies were not performed with the proposed biosimilar. Here, we review the approval process for biosimilars, focusing on the licensing of bevacizumab biosimilars and their extrapolation to metastatic colorectal cancer.
PB Elsevier
YR 2020
FD 2020-10-26
LK http://hdl.handle.net/10668/16675
UL http://hdl.handle.net/10668/16675
LA en
NO Taïeb J, Aranda E, Raouf S, Dunn H, Arnold D. Clinical and Regulatory Considerations for the Use of Bevacizumab Biosimilars in Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2021 Mar;20(1):42-51.e3
DS RISalud
RD Apr 19, 2025