This symposium took place on 18th October 2016 as a part of the United European Gastroenterology (UEG) Week in Vienna, Austria
Moderator: Simon Travis1
Faculty: Geert R. D’Haens,2 Julián Panés,3 Stefan Schreiber4
1. Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK
2. Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, Netherlands
3. Department of Gastroenterology, Hospital Clinic Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain
4. Clinic of Internal Medicine, Christian-Albrechts University, Kiel, Germany
Disclosure: Prof Simon Travis has been an advisor to, in receipt of educational or research grants from, or an invited lecturer for AbbVie, Amgen, Asahi, Biogen, Boehringer Ingelheim, BMS, Cosmo, Elan, Ferring, FPRT Bio, Genentech/Roche, Genzyme, Glenmark, GW Pharmaceuticals, Lilly, Merck, Novartis, Novo Nordisk, Ocera, Pfizer, Receptos, Shire, Santarus, SigmoidPharma, Synthon, Takeda, Tillotts, Topivert, Trino Therapeutics with Wellcome Trust, UCB Pharma, Vertex, VHsquared, Vifor, Warner Chilcott, and Zeria. All advisory boards were suspended 2012–14 whilst President of ECCO. Prof Geert R D’Haens has served as an advisor for Abbvie, Ablynx, Amakem, AM Pharma, Avaxia, Biogen, BMS, Boerhinger Ingelheim, Celgene, Celltrion, Cosmo, Covidien, Ferring, DrFALK Pharma, Engene, Galapagos, Gilead, Glaxo Smith Kline, Hospira, Immunic, Johnson and Johnson, Lycera, Medimetrics, Millenium/Takeda, Mitsubishi Pharma, Merck Sharp & Dohme, Mundipharma, Novonordisk, Pfizer, Prometheus laboratories/Nestle, Protagonist, Receptos, Robarts Clinical Trials, Salix, Sandoz, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant, and Vifor, and has received speaker fees from AbbVie, Ferring, Johnson and Johnson, Merck Sharp & Dohme, Mundipharma, Norgine, Pfizer, Shire, Millenium/Takeda, Tillotts, and Vifor. Dr Julián Panés has been advisor to, in receipt of educational or research grants from, or an invited lecturer for AbbVie, Biogen, Boehringer Ingelheim, Celgene, Ferring, Galapagos, Genentech/Roche, GSK, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Takeda, TiGenix, and Topivert. Prof Stefan Schreiber has received honoraria from Biogen.
Acknowledgements: Writing assistance provided by Juliette Allport, Ashfield Healthcare Communications Ltd.
Support: Biogen provided funding for medical writing support in the development of this article. Biogen reviewed the article for medical accuracy and provided feedback to the authors. All named authors had full editorial control of the paper, and provided their final approval of all the content.
Citation: EMJ Gastroenterol. 2016;5:34-41.
Biosimilars follow a rigorous regulatory approval pathway designed to collect and review the totality of evidence from non-clinical analytical comparability exercises as well as clinical Phase I and III studies between the biosimilar and the reference biological. Once the European Medicines Agency (EMA) has given a positive opinion on the generated totality of evidence, the agency may extrapolate the biosimilar’s clinical data from the indication in which the biosimilar was studied to other indications for which the reference biological was approved. A prerequisite for this step is a convincing demonstration of biosimilarity within a studied clinical Phase III population that is suitably sensitive to detect potential clinically relevant differences in efficacy, safety, or immunogenicity. This regulatory pathway was used for all currently available biosimilars including SB2 (Flixabi®), a recently approved biosimilar that is licensed for use across all indications approved for its reference biologic infliximab (Remicade®), including inflammatory bowel disease (IBD). Further to robust non-clinical evaluations of SB2 in 46 physicochemical and 23 biological assays, a Phase I study demonstrated pharmacokinetic equivalence between SB2 and reference infliximab. Furthermore, a Phase III study performed in patients with moderate-to-severe rheumatoid arthritis (RA) — a scientifically appropriate, sensitive patient population — showed that SB2 was equivalent to infliximab in terms of its primary endpoint, American College of Rheumatology 20% improvement (ACR20) response rate at Week 30, and comparable with regard to safety and immunogenicity up to Week 54. Additional analyses of treatment-emergent adverse events (TEAEs) by anti-drug antibody (ADA) status up to Week 54 demonstrated a comparable incidence of TEAEs in both treatment arms. The ACR response rates, safety, and incidence of ADAs remained comparable also in the transition extension period up to Week 78 between patients who continued to receive either SB2 or reference infliximab, and patients who transitioned from reference infliximab to SB2. Biosimilars have an important place in the treatment of IBD. Increased use of biosimilars in patients with Crohn’s disease (CD) or ulcerative colitis is likely to reduce costs, expand access of eligible patients to biologic therapy, and improve overall health outcomes.