SP0024 An up-date on biosimilars
Authors: T.K. Kvien
Journal: Annals of the Rheumatic Diseases (2018)

<h3></h3> Biosimilars represent a new opportunity for lowering the cost of treatment with biological disease-modifying antirheumatic drugs (bDMARDs). Studies have demonstrated large inequities in the access to bDMARDs across countries and this inequity is related to economic parameters such as gross domestic product. Thus, reduced costs of bDMARDs should potentially lead to better treatment for more patients, especially in countries with low economy. The regulatory agencies in Europe and in US have set up strict guidelines for approval of biosimilars which include extensive pre-clinical examinations (structure and functional characteristics) but less clinical data than for an originator product. The clinical part of this comparability exercise focuses on efficacy, safety, pharmacokinetics as well as immunogenicity. Three biosimilars to adalimumab have also been approved but the patent of the reference product has not yet expired (expected to occur October 2018). (expected to occur October 2018). It is a growing acceptance about the use of these biosimilars, also in extrapolated indications when treatment are started or changed for medical reasons. Most rheumatologists will consider the biosimilars on the same level as originator products in these situations. However, replacing an originator product by a biosimilar is more controversial, but is important because of the large cost-savings. Switching evidence is available from four different types of studies which will be discussed: Extension of phase 3 RCTs Switching within RCTs Real life data (eg from DANBIO) Randomising patients on stable long–term treatment In the NOR-SWITCH trial totally funded by the Norwegian government 482 patients on stable treatment with the reference product infliximab across 6 indications (RA, SpA, PsA, UC, CD, PsO) were randomised to continued treatment with the reference product or switch to the biosimilar CT-P13; Jørgensen KK et al. Lancet 2017389:2304–2316). The primary endpoint was occurrence of disease worsening, defined by the disease-specific composite measures or clinically significant worsening leading to a major change in treatment. Overall, disease worsening occurred in 26.2% of patients who continued treatment with the originator infliximab and in 29.6% of patients who switched to CT-13. The adjusted treatment difference (95% CI) was −4.4% (−12.7–3.9) which was within the prespecified non-inferiority margin of −15%. The occurrence of adverse events, including infusion reactions, was similar across both groups. There were no differences between the two groups in secondary endpoints, including time to study drug discontinuation, remission rates, CRP levels, anti-drug antibody formation and drug trough levels. The extension study (not yet published) showed that switching from originator to biosimilar was not inferior to continued treatment with the biosimilar. In conclusion, the NOR-SWITCH study demonstrated that switching to CT-P13 was not inferior to continued treatment with originator infliximab, adding to the increasing real-world evidence that switching from originator to biosimilar bDMARD is safe and efficacious. <h3>Disclosure of Interest</h3> T. Kvien Consultant for: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Epirus, Hospira, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB