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Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis

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Zhao S1, Chadwick L1, Mysler E2, Moots RJ3.Author informationCurr Rheumatol Rep. 2018 Aug 9;20(10):57. doi: 10.1007/s11926-018-0769-6.

Abstract

1 Department of Musculoskeletal Biology I, Clinical Sciences Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Aintree University Hospital, Longmoor Lane, Liverpool, L9 7AL, UK.

2 Organización Medica de Investigación, Buenos Aires, Argentina.

3 Department of Musculoskeletal Biology I, Clinical Sciences Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Aintree University Hospital, Longmoor Lane, Liverpool, L9 7AL, UK. rjmoots@liv.ac.uk.

Abstract

PURPOSE OF REVIEW: Adalimumab is one of the top-selling drugs worldwide. Its imminent patent expiration has seen the emergence of numerous biosimilar agents. In this article, we recap the evidence from bio-originator trials in rheumatoid arthritis(RA) to provide context for a critical review of biosimilar trial data.

RECENT FINDINGS: Currently, three adalimumab biosimilars are approved in Europe and/or the USA: Amgen's ABP 501 (AMJEVITA/Solymbic), Boehringer Ingelheim's BI 695501 (Cyltezo) and Samsung Bioepis's SB5 (Imraldi). All three agents met their pre-specified equivalence criteria. Subtle differences in adverse events and clinical responses between the reference and biosimilar products were noted. The introduction of adalimumab biosimilars will offer exciting opportunities in improving treatment access and increasing treatment options for RA and other licensed indications. Real-world data will further provide assurances on efficacy as well as safety.