Positive Safety Outcomes When Switching Between Biosimilars and Reference Biologics

A systematic review and meta-analysis published in PLOS ONE finds no difference in safety profiles or immunogenicity rates for patients who switched between reference biologics and biosimilars, providing reassurance for concerns about switching stable patients to biosimilars. 

Biosimilars, highly similar and safe biological products, are an important strategy for reducing drug costs and increasing access to medicine. Concerns about switching patients to biosimilars from reference biologics have been addressed in reviews, which found no significant safety issues. Studies on switching and interchangeability are ongoing, but current evidence suggests that switching between biosimilars and reference biologics does not pose additional risks to patients. 

A systematic review was conducted following the Systematic Reviews and Meta-Analyses (PRISMA) statement guidelines. Searches were performed from January 2000 through December 2022.  

“FDA databases containing publicly available information were reviewed for all clinical studies submitted as part of a BLA for an approved biosimilar,” said researchers. “Information not captured in FDA reviews was identified by searching the Embase. MEDLINE, and PubMed databases.”  

Two reviewers independently screened and assessed the eligibility of articles based on specific criteria. Data extraction included various factors such as study design, demographics, safety data, and immunogenicity. Data synthesis was done qualitatively and quantitatively, and meta-analyses were performed using statistical methods. Additional data was included from clinical study reports when necessary. 

A total of 552 records were identified through the search process, and after applying eligibility criteria, 44 studies were included in the analysis. These studies were randomized double-blind controlled studies or open-label extensions of a parent study. The included studies involved the switching of patients between a reference biologic and a corresponding biosimilar, with 44 distinct switch treatment periods identified. The study included a total of 5,252 patients from various populations, with a focus on patients with rheumatoid arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis. The analysis of safety outcomes showed no significant differences in the risk of death, serious adverse events, or treatment discontinuations between the switching and not switching across all switch treatment periods. 

"This first systematic review using statistical methods to address the risk of switching patients between reference biologics and biosimilars finds no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar," said researchers. 

Reference  

Herndon TM, Ausin C, Brahme NN, et al. Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis. PLOS ONE. 2023;18(10): e0292231. doi:10.1371/journal.pone.0292231