Related Experiment Video
Updated: Aug 12, 2025
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis
HyeJung Na1, Sun-Hong Kwon2, Kyung-Hwa Son1
1School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeonggi-do, Republic of Korea.
Background:
It is crucial that the safety profiles of biosimilars are similar to those of the original biologics. A better understanding of biosimilars and their relative safety and immunogenicity profiles are required for healthcare providers to prescribe them to patients with life-threatening cancer diseases who receive chemotherapies with potentially serious adverse events (AEs).
Objectives:
The purpose of this study was to collate and analyze currently available safety and immunogenicity outcomes of biosimilars used in oncology and compare their safety information with those of the original biologics.
Methods:
The MEDLINE and Cochrane Library databases were searched as at 28 February 2022. Four anti-cancer biosimilar molecules were considered: bevacizumab, trastuzumab, rituximab, and (peg)filgrastim. Through a systematic review, we selected the randomized controlled trials (RCTs) comparing safety outcomes between the biosimilars and original biologics of the four molecules. As safety outcomes, various treatment-emergent adverse events (TEAEs) were collated, such as any TEAE, serious AE, and TEAE higher than grade 3. A risk ratio (RR) per category of TEAE was estimated through a meta-analysis. A network meta-analysis (NMA) was also conducted to compare the safety among the biosimilar brands for TEAEs over 25% with higher variability in addition to the serious AE cases.
Results:
Forty-nine RCTs were identified. The results from the meta-analysis showed that the safety and immunogenicity profiles of all four biosimilar molecules are comparable with that of the original biologics at the TEAE level without statistically significant differences, except for diarrhea for (peg)filgrastim. The incidence of diarrhea with (peg)filgrastim was less than that with the original biologic (RR 0.66, 95% confidence interval 0.50-0.89). The NMA results showed similar safety profiles among the biosimilar brands for all four biosimilar molecules, except for the serious adverse event of a trastuzumab biosimilar (RR 0.296, 95% credible interval 0.109-0.840).
Conclusion:
The meta-analysis and NMA for all four biosimilars showed that the safety and immunogenicity profiles of biosimilar products in oncology are generally comparable with that of the original biologics at the TEAE level. However, additional evidence needs to be collected since several TEAEs of specific biosimilars were out of the equivalent range. The results of this study provide comparative safety information and a better understanding of oncology biosimilars for healthcare providers to prescribe them to patients.
Insights
Biosimilar oncology drugs show comparable safety and immunogenicity to original biologics, with minor exceptions in specific adverse events. This review provides crucial data for healthcare providers prescribing these vital cancer treatments.
Area of Science:
- Oncology
- Pharmacology
- Biotechnology
Background:
- Biosimilars require safety profiles similar to original biologics for clinical adoption.
- Understanding biosimilar safety and immunogenicity is crucial for oncologists treating patients with life-threatening cancers.
Approach:
- Systematic review and meta-analysis of randomized controlled trials (RCTs) comparing four oncology biosimilars (bevacizumab, trastuzumab, rituximab, (peg)filgrastim) against their original biologics.
- Network meta-analysis (NMA) was performed to compare safety among biosimilar brands.
Key Points:
- Meta-analysis revealed comparable safety and immunogenicity profiles for all four biosimilars versus originators at the treatment-emergent adverse event (TEAE) level.
- (Peg)filgrastim showed significantly less diarrhea compared to its originator.
- NMA indicated similar safety among biosimilar brands, with one exception for a trastuzumab biosimilar's serious adverse event.
Conclusions:
- Oncology biosimilars generally exhibit comparable safety and immunogenicity to original biologics.
- Further evidence is needed for specific TEAEs falling outside equivalence ranges.
- This study offers valuable comparative safety insights to guide healthcare providers in prescribing oncology biosimilars.
Related Concept Videos
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:16Bioequivalence: Overview
01:20Comparing the Survival Analysis of Two or More Groups
01:21Cancer Survival Analysis
01:12Hazard Ratio
For example, in a clinical trial...
01:26Pharmacokinetic Models: Comparison and Selection Criterion
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.