Jichun Yang1, Shuqing Yu1, Zhirong Yang2, Yusong Yan1, Yao Chen1, Hongmei Zeng3, Fei Ma4, Yanxia Shi5, Yehui Shi6, Zilu Zhang7, Feng Sun8. 1. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China. 2. Primary Care Unit, School of Clinical Medicine, University of Cambridge, Cambridgeshire, CB18RN, UK. 3. Department of Cancer Registry, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. 4. Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. 5. Department of Medical Oncology, Sun Yat-Sen University Cancer Center/State Key Laboratory of Oncology in South China/Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China. 6. Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300060, China. 7. Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, 02215, USA. 8. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China. sunfeng@bjmu.edu.cn.
Abstract
BACKGROUND: Many biosimilars of monoclonal antibodies (mAbs) are becoming increasingly available as anticancer therapies, such as the rituximab, bevacizumab, and trastuzumab biosimilars. However, no comprehensive summary of their efficacy and safety is available. OBJECTIVE: This study synthesized current evidence on the efficacy and safety of mAb biosimilars relative to their reference biologics among cancer patients. METHODS: We searched PubMed, Embase, the Cochrane library, ClinicalTrials.gov, the ISI Web of Science, and several Chinese databases from their inception dates to December 31, 2018, for randomized controlled trials (RCTs) or comparative observational studies that compared the efficacy and safety of biosimilars with reference biologics used in oncology. The binary outcomes were pooled using risk ratio (RR) with 95% confidence intervals (CIs), continuous outcomes using weighted mean difference (WMD) with 95% CIs, and time-to-event outcomes using hazard ratios (HRs). Subgroup and sensitivity analyses were conducted following this. We used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach to rate the quality of the evidence. RESULTS: We did not find any comparative observational studies that fit the criteria. Twenty-three RCTs were identified for biosimilars of three mAbs, of which eight RCTs examined rituximab biosimilars (total N = 1534), six RCTs were for bevacizumab biosimilars (total N = 1897), and nine were for trastuzumab biosimilars (total N = 4953), respectively. The quality of the GRADE evidence for efficacy and safety outcomes was moderate or low. The findings were robust for all pre-specified subgroup and sensitivity analyses. CONCLUSION: The existing evidence suggests highly comparable efficacy and safety profiles between mAb biosimilars and their reference biologics in oncological drugs.
BACKGROUND: Many biosimilars of monoclonal antibodies (mAbs) are becoming increasingly available as anticancer therapies, such as the rituximab, bevacizumab, and trastuzumab biosimilars. However, no comprehensive summary of their efficacy and safety is available. OBJECTIVE: This study synthesized current evidence on the efficacy and safety of mAb biosimilars relative to their reference biologics among cancerpatients. METHODS: We searched PubMed, Embase, the Cochrane library, ClinicalTrials.gov, the ISI Web of Science, and several Chinese databases from their inception dates to December 31, 2018, for randomized controlled trials (RCTs) or comparative observational studies that compared the efficacy and safety of biosimilars with reference biologics used in oncology. The binary outcomes were pooled using risk ratio (RR) with 95% confidence intervals (CIs), continuous outcomes using weighted mean difference (WMD) with 95% CIs, and time-to-event outcomes using hazard ratios (HRs). Subgroup and sensitivity analyses were conducted following this. We used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach to rate the quality of the evidence. RESULTS: We did not find any comparative observational studies that fit the criteria. Twenty-three RCTs were identified for biosimilars of three mAbs, of which eight RCTs examined rituximab biosimilars (total N = 1534), six RCTs were for bevacizumab biosimilars (total N = 1897), and nine were for trastuzumab biosimilars (total N = 4953), respectively. The quality of the GRADE evidence for efficacy and safety outcomes was moderate or low. The findings were robust for all pre-specified subgroup and sensitivity analyses. CONCLUSION: The existing evidence suggests highly comparable efficacy and safety profiles between mAb biosimilars and their reference biologics in oncological drugs.
Authors: Pekka Kurki; Hye-Na Kang; Niklas Ekman; Ivana Knezevic; Martina Weise; Elena Wolff-Holz Journal: BioDrugs Date: 2022-05-21 Impact factor: 7.744
Authors: Eric Chabrol; Charline Fagnen; Sophie Landron; Estelle Marcheteau; Johann Stojko; Sophie-Pénélope Guenin; Mathias Antoine; Benjamin Fould; Gilles Ferry; Jean A Boutin; Catherine Vénien-Bryan Journal: Protein Sci Date: 2021-06-17 Impact factor: 6.993