Biosimilars and Switching: What Is Your Perspective?

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)