Biosimilar switching – current state of knowledge
More details
Hide details
Submission date: 2018-05-21
Final revision date: 2018-07-24
Acceptance date: 2018-07-25
Online publication date: 2018-08-31
Publication date: 2018-08-31
Reumatologia 2018;56(4):234-242
Evidence from over 10 years of clinical experience demonstrates that biosimilar medicines approved in the European Union can be used for all their registered indications as safely as their originators and with no negative impact on therapeutic efficacy. The debate on the use of biosimilars in rheumatology focuses specifically on the safety of switching between biosimilars and reference products. Studies conducted to date, including randomised double-blind and open-label extension trials, have not demonstrated any significant differences in therapeutic efficacy or safety between patients switched from one medicine to another and those who were continued on a single medicine. According to the latest recommendations for the use of biosimilars in rheumatic diseases, developed by an international task force in 2017, there is no clinical evidence that a single switch from an originator to a biosimilar medicine is associated with any significant risk for patient safety or reduction in therapeutic efficacy.
Summary of Product Characteristics Omnitrope, 2017; http://www.ema.europa.eu/docs/... (accessed 12.12.2017).
Biosimilars in the EU. Information guide for healthcare professionals; EMA, EC 2017; http://www.ema.europa.eu/ docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf (accessed 12.12.2017).
Kucharz EJ, Stajszczyk M, Batko B, et al. Biopodobne leki biologiczne w reumatologii. Forum Reumatol 2017; 3: 191-204.
Dörner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol 2015; 11: 713-724.
www.ema.europa.eu (accessed 17.05.2018).
https://english.cbg-meb.nl/ (accessed 10.01.2018).
Kay J, Schoels MM, Dörner T, et al. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis 2018; 77: 165-174.
Considerations in Demonstrating Interchangeability With a Reference Product. Guidance for industry. Draft guidance. 2017; https://www.fda.gov/downloads/... (accessed 11.01.2018).
Griffiths CE, Thaçi D, Gerdes S, et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2017; 176: 928-938.
Kurki P, van Aerts L, Wolff-Holz E, et al. Interchangeability of biosimilars: A European perspective. BioDrugs 2017; 31: 83-91.
McCamish M, Woollett GR. Molecular Sameness Is Key Guiding Principle for Extrapolation to Multiple Indications. Clin Pharmacol Ther 2017; 101: 603-605.
Strandt V, Balsa A, Al-Saleh J, et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review. BioDrugs 2017; 31: 299-316.
Park W, Yoo DH, Jaworski J, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54 weeks results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther 2016; 18: 25.
Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54 week results from PLANETRA study. Arthritis Res Ther 2016; 18: 82.
Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther 2012; 12: 1473-1485.
Lopez-Siguero JP, Pfaffle R, Chanson P, et al. Ten years’ clinical experience with biosimilar human growth hormone: a review of efficacy data. Drug Des Devel Ther 2017; 11: 1489-1495.
Borras-Perez MV, Kristrom B, Romer T, et al. Ten years’ clinical experience with biosimilar human growth hormone: a review of safety data. Drug Des Devel Ther 2017; 11: 1497-1503.
Blackwell K, Semiglazov V, Krasnozhon D, et al. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patient with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol 2015; 26: 1948-1953.
Gerdes S, Thaci D, Griffiths CEM, et al. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque type psoriasis: 30 weeks results from the phase 3, confirmatory study. J Eur Acad Dermatol Venereol 2018; 32: 420-427.
Jørgensen K, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017; 389: 2304-2316.
Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2017; 76: 355-363.
Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 2017; 76: 346-354.
Glintborg B, Sorensen IJ, Loft AG, et al. Nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1 year clinical outcomes from the DANBIO study. Ann Rheum Dis 2017; 76: 1426-1431.
Emery P, Vencovsky J, Sylwestrzak A, et al, Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4. Ann Rheum Dis 2017; 76: 1986-1991.
Papp K, Bachelez H, Costanzo A, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol 2017; 76: 1093-1102.
Moots R, Azevedo V, Coindreau JL, et al. Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology and Dermatology Inflammatory Conditions: Considerations of the Clinicians. Curr Rheumatol Rep 2017; 19: 37.
Petersen GL, Finnerup NB, Colloca L, et al. The magnitude of nocebo effects in pain: a meta-analysis. Pain 2014; 155: 1426-1434.
Tweehuysen L, van den Bemt, van Ingen IL, et al. Subjective Complaints as the Main Reason for Biosimilar Discontinuation after Open-Label Transitioning from Originator to Biosimilar Infliximab. Arthritis Rheumatol 2018; 70: 60-68.
Inotai A, Prins CP J, Csanadi M, et al. Is there a reason for concern or is it just a hype? A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars. Expert Opin Biol Ther 2017; 17: 915-926.
Copyright: © Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji w Warszawie. This is an Open Access journal, all articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License (https://creativecommons.org/licenses/by-nc-sa/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
Journals System - logo
Scroll to top