Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes

Abstract

IntroductionTo evaluate the possibility that switching from reference biologic medicines to biosimilars could lead to altered clinical outcomes, including enhanced immunogenicity, compromised safety, or diminished efficacy for patients, a systematic literature review was conducted of all switching studies between related biologics (including biosimilars).MethodsA systematic search was conducted using the Medline® and Embase® databases up to 30 June 2017 employing specific medical subject heading terms. Additionally, the snowball method and a hand search were also applied. Publications were considered if they contained efficacy or safety information related to a switch from a reference medicine to a biosimilar. Non-English, non-human studies, editorials, notes, and short surveys were excluded.ResultsPrimary data were available from 90 studies that enrolled 14,225 unique individuals. They included protein medicines used in supportive care as well as those used as therapeutic agents. The medicines contained seven different molecular entities that were used to treat 14 diseases. The great majority of the publications did not report differences in immunogenicity, safety, or efficacy. The nature and intensity of safety signals reported after switching from reference medicines to biosimilars were the same as those already known from continued use of the reference medicines alone. Three large multiple switch studies with different biosimilars did not show differences in efficacy or safety after multiple switches between reference medicine and biosimilar. Two publications reported a loss of efficacy or increased dropout rates.ConclusionsWhile use of each biologic must be assessed individually, these results provide reassurance to healthcare professionals and the public that the risk of immunogenicity-related safety concerns or diminished efficacy is unchanged after switching from a reference biologic to a biosimilar medicine.Electronic supplementary materialThe online version of this article (10.1007/s40265-018-0881-y) contains supplementary material, which is available to authorized users.

Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn's disease in Asia

“…Cohen et al . conducted a systematic review of switching reference medicines to biosimilars . Ninety studies were identified involving seven agents that treated 14 disease indications and enrolled a total of 14 225 individuals.…”

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