This satellite symposium took place on 16th June 2017 as a part of the European League Against Rheumatism (EULAR) Congress in Madrid, Spain
Chairperson: John Isaacs1
Speakers: John Isaacs,1 Guro Løvik Goll,2 João Gonçalves,3 Ailsa Bosworth4
1. Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
2. Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
3. iMed – Research Institute of Medicines, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal
4. National Rheumatoid Arthritis Society, Maidenhead, UK
Disclosure: Prof John Isaacs has received consultancy fees from AbbVie, BMS, Celltrion, Chugai, Eli Lilly, Hospira, Janssen, Merck Serono, Pfizer, and Roche; lecturing fees from Biogen, Pfizer, and Roche; and grants/research support from Pfizer. Dr Guro Løvik Goll has received honoraria or consultancy fees from AbbVie, Boehringer Ingelheim, Novartis, Orion Pharma, Pfizer, and Sandoz. Prof João Gonçalves has collaborated in research projects with UCB, Sandoz, Janssen, Merck (MSD), Pfizer, and TechnoPhage; and received consultancy fees from EMA/Infarmed, MSD, Novartis, UCB, Merck Serono, Lilly, Medtronic, Roche, Hospira/Pfizer, Celltrion Healthcare, Antibody Technologies, Ablynx, and Biogen. Ms Ailsa Bosworth has declared no conflicts of interest.
Acknowledgements: Writing assistance was provided by Janet Fricker.
Support: The symposium was sponsored by Sandoz.
Citation: EMJ Rheumatol. 2017;4:34-41.
The licensing of biosimilars heralds the start of a new era for physicians treating immune and inflammatory diseases. This symposium provided an update on biosimilar drugs and dealt with questions and concerns around switching from a reference biological drug to its biosimilar.
Prof Isaacs presented the physician’s perspective, describing the regulatory process that is designed to provide reassurance regarding clinical equivalence for biosimilars alongside comparable safety and immunogenicity data. A current consequence of a range of different clinical trial designs is that biosimilars cannot be compared. As more biosimilars enter the market, he made the case for the standardisation of clinical trial designs to simplify comparisons between the different biosimilars. Dr Goll gave an overview of the NOR-SWITCH study. The Norwegian government-funded study showed that switching from reference infliximab (INX) to the biosimilar CT-P13 was not inferior to continued treatment with INX.
Prof Gonçalves shared the pharmacist’s perspective and explained that post-approval pharmacovigilance is crucial for consolidating confidence in biosimilars. He presented studies showing that there was no evidence for biosimilar-related immunogenicity beyond the reference molecule. He concluded that in pharmacovigilance all switching information obtained in registries should be pooled with voluntarily reported and suspected adverse-drug reactions.
Ms Bosworth focussed on the views and needs of patients with regard to key issues associated with switching to biosimilar drugs. She stated honesty and transparency were required when explaining the reasons for switching and that healthcare staff should not hide the fact that saving money is the reason for switching. Financial savings resulting from introducing biosimilars, she stressed, should be shared between commissioners, hospital units, and rheumatology teams. A range of resources on biosimilars for both health professionals and patients are available from the National Rheumatoid Arthritis Society (NRAS).
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