Abstract
The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD)
was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab
and five for adalimumab) have been approved and licensed by the European Medicines
Agency. Biosimilars present great potential in terms of cost saving and possible consequential
reinvestment in the health care system. The increasing knowledge about the process
of biosimilar development and use in IBD and the publication of many prospective clinical
studies and real-life clinical experiences have progressively changed the point of
view of IBD physicians. In the present position paper, the Italian Group for the Study
of Inflammatory Bowel Disease present and discuss their updated statements and positions
on this topic, with emphasis on the concepts of biosimilarity and extrapolation across
indications, safety and immunogenicity, interchangeability and switching, automatic
substitution, and, finally, patient education about biosimilars.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Digestive and Liver DiseaseAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Guidelines on evaluation of similar biotherapeutic products (SBPs) Expert Committee on Biological Standardization.2009
- Biosimilars in the EU: information guide for healthcare professionals.2017
https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita/solymbic.
- Biosimilars in IBD: from theory to practice.Nat Rev Gastroenterol Hepatol. 2017; 14: 22-31
- Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn’s and Colitis Organization.J Crohns Colitis. 2014; 8: 1548-1550
- Use of biosimilars in inflammatory bowel disease: statements of the Italian Group for Inflammatory Bowel Disease.Dig Liver Dis. 2014; 46: 963-968
- Joint position statement by Spanish Society of Gastroenterology and Spanish Society of Pharmacology on biosimilar therapy for inflammatory bowel disease.Rev Esp Enferm Dig. 2013; 105: 37-43
- ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD).J Crohns Colitis. 2013; 7: 586-589
- The use of biosimilars in immune-mediated disease: a joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper.Autoimmun Rev. 2014; 13: 751-755
- Clinical and scientific aspects related to biosimilars in inflammatory bowel diseases (IBD): position document of the Belgian IBD Research & Development Group (BIRD).Acta Gastroenterol Belg. 2015; 78: 26-29
- Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis — experiences from a single center.Expert Opin Biol Ther. 2015; 15: 1257-1262
- Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis.J Crohns Colitis. 2016; 10: 1273-1278
- Clinical experience of the use of CT-P13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series.Dig Dis Sci. 2015; 60: 951-956
- Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea.Expert Rev Gastroenterol Hepatol. 2015; 9: 35-44
- Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations.J Crohns Colitis. 2016; 10: 127-132
- Clinical outcomes following a switch from remicade(R) to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study.J Crohns Colitis. 2016; 10: 1287-1293
- Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort.J Crohns Colitis. 2016; 10: 133-140
- Changes in biosimilar knowledge among European Crohn’s Colitis Organization [ECCO] members: an updated survey.J Crohns Colitis. 2016; 10: 1362-1365
- 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
- The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar.Inflamm Bowel Dis. 2017; 23: 233-243
- The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the effectiveness and safety across Italy.Inflamm Bowel Dis. 2018; https://doi.org/10.1093/ibd/izy264
- Effectiveness and safety of reference infliximab and biosimilar in crohn disease: a French equivalence study.Ann Intern Med. 2019; 170: 99-107
European Medicine Agency. Biosimilar medicines. https://www.ema.europa.eu/human-regulatory/overview/biosimilar-medicines.
- Guideline on similar biological medicinal products containing monoclonal antibodies—non-clinical and clinical issues (EMA/CHMP/BMWP/403543/2010 Committee for Medicinal Products for Human Use).2012
- A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.Ann Rheum Dis. 2013; 72: 1605-1612
- A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study.Ann Rheum Dis. 2013; 72: 1613-1620
- Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study.Ann Rheum Dis. 2018; 77: 234-240
- Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results.Rheumatology (Oxford). 2017; 56: 1771-1779
- A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.Ann Rheum Dis. 2017; 76: 58-64
- A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.Arthritis Res Ther. 2018; 20: 155
- Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.Ann Rheum Dis. 2017; 76: 1679-1687
- 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
- Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis.Arthritis Rheumatol. 2018; 70: 40-48
- Switching from reference adalimumab to SB5 (adalimumab biosimilar) in patients with rheumatoid arthritis: fifty-two-week phase III randomized study results.Arthritis Rheumatol. 2018; 70: 832-840
- Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study.Ann Rheum Dis. 2018; 77: 914-921
- A randomized, double-blind, parallel-group, multicenter study to compare the efficacy, safety and immunogenicity of a proposed adalimumab biosimilar (GP2017) with reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis.Arthritis Rheumatol. 2018; 70: A1936
- Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches.Br J Dermatol. 2018; 179: 623-631
- Efficacy, safety and immunogenicity in randomized double-blind (DB) and open-label extension (OLE) studies comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product (Humira®; RP) in patients (pts) with active rheumatoid arthritis (RA).Arthritis Rheumatol. 2017; 69: 2
- Efficacy and safety results of a phase III study comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product in patients with active rheumatoid arthritis.Ann Rheum Dis. 2017; 76: 59
- Biosimilars: the science of extrapolation.Blood. 2014; 124: 3191-3196
- Secondo Position Paper AIFA sui Farmaci Biosimilari.2018
- Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes.Drugs. 2018; 78: 463-478
- Full interchangeability in regard to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease.Inflamm Bowel Dis. 2018; 24: 601-606
- Multisource (Generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability World Health Organization WHO technical report series.937 ed. 2006
- Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease.Ther Adv Gastroenterol. 2018; 11 (1756284818801244)
- ECCO position statement on the use of biosimilars for inflammatory bowel disease—an update.J Crohns Colitis. 2017; 11: 26-34
- Biosimilars: what do patients need to consider?.RMD Open. 2015; 1: e000141
- The nocebo effect: a clinical challenge in the era of biosimilars.Expert Rev Clin Immunol. 2018; 14: 739-749
- Patient attitudes and understanding about biosimilars: an international cross-sectional survey.Patient Prefer Adherence. 2016; 10: 937-948
- Patient perspectives on biosimilars: a survey by the european federation of crohn’s and ulcerative colitis associations.J Crohns Colitis. 2017; 11: 128-133
Article info
Publication history
Published online: February 19, 2019
Accepted:
February 4,
2019
Received:
January 16,
2019
Identification
Copyright
© 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
