Evidence suggests that biosimilars and both safe and effective for use in oncology, according to the results of a recent study published in Bio Drugs.
In recent years, biologics have been widely used to manage and reduce the side effects of cancer treatment (i.e. epoetin alfa is provided to treat chemotherapy-induced anemia [CIA] while granulocyte colony-stimulating factors [G-CSFs] are used to treat chemotherapy-induced neutropenia [CIN]). As more and more biologic patents reach their expiry, companies have developed biosimilars to the “originator” biologics (i.e., epoetin alfa biosimilar, filgrastim biosimilar, and pegfilgrastim biosimilar).
In assessing the efficacy of biosimilars in oncology, researchers combed through several databases including: PubMed, Embase, the Cochrane Library, ClinicalTrials.gov, and ISI Web of Science from inception through December 2018 for randomized controlled trials (RCTs) or similar studies that compared the safety and efficacy of biosimilars to their referenced biologic in oncology. In evaluating data, they separated RCTs and observational studies because the two constitute different patient populations and designs. The researchers also implemented risk ratios (RR) with confidence intervals (CIs) and continuous outcomes with weight mean differences (WMD) with 95% CIs to assess binary outcomes. To rate the quality of their findings, they used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
According to the study results, the RCTs and observational studies that compared RCTs to referenced biologics indicate comparable safety and efficacy. “Overall, there was no statistically significant difference in any efficacy or safety outcomes between any biosimilars and their corresponding original biologics,” the study authors wrote. Moreover, the efficacy and safety outcomes were found to be moderate or low based on GRADE scoring.
“These findings were robust are we performed considerable sensitivity analyses,” the authors continued, adding that “further studies are needed to confirm our conclusions.”