EFFICACY AND SAFETY OF BIOSIMILARS IN ONCOLOGY- A SYSTEMATIC REVIEW AND META-ANALYSIS

OBJECTIVES

: The monoclonal antibodies(mAb) therapies that offer a possibility of individualized treatment based on the molecular profile of the tumor improve survival and quality of life and reduce side effects.With a number of mAb in oncology in facing patent expiration, many companies all over the world have established mAb biosimilars(e.g., rituximab, bevacizumab, and trastuzumab).Biosimilars are products that are highly similar efficacy and safety to biologics that has already been approved.This systematic review aims to compare clinical efficacy and safety of mAb biosimilars to reference products in oncology.

METHODS

: PubMed,Embase, the Cochrane library, ClinicalTrials.gov, the Chinese databases and a hand-search were performed from inception to the end of 31 May 2017.The outcomes of mAb biosimilars include: efficacy outcomes (overall response rate (ORR), overall survival rate(OS), progression free survival rate(PFS)) and safety outcomes (AE rate).Data were analysed separately for rituximab biosimilars, bevacizumab biosimilars and trastuzumab biosimilars.Data extracted from the studies were pooled by using risk ratio(RR) with their corresponding 95 % CIs.Results for each outcome of RCTs plus observational studies were presented as a pooled rate with 95% CIs.

RESULTS

: The remaining 15 English-language studies were included in this review:6 RCTs and 2 case series studies of rituximab biosimilars;3 RCTs of bevacizumab biosimilars;4 RCTs of trastuzumab biosimilars.Efficacy and safety outcomes in rituximab biosimilars and rituximab were equivalent:ORR(RR=1.00,95%CI:0.95～1.05),AE rate(RR=1.20, 95% CI:0.94～1.52);Efficacy and safety outcomes in bevacizumab biosimilasr and bevacizumab were equivalent:ORR(RR=0.94, 95% CI:0.81～1.10),PFS rate (RR=0.67,95%CI: 0.11～3.93);Efficacy and safety outcomes in trastuzumab biosimilars and trastuzumab were equivalent:ORR(RR=1.06, 95% CI:0.99～1.13),OS rate(RR=1.09,95%CI: 0.95～1.24);PFS rate(RR=0.99,95%CI: 0.81～1.22), AE rate(RR=1.04, 95% CI:0.89～1.22). In addition, pooled rate of RCTs plus case series studies showed similar ORR and AE rate in rituximab biosimilars and rituximab.

CONCLUSIONS

: The results have proven the similar efficacy and safety profile of mAb biosimilars compared to their own reference products.Further studies,continuous data collection and benefit-risk assessment might confirm our results.