LAUSR

This issue of the BJD includes an important paper from the International Psoriasis Council Biosimilars Working Group, which gives a global perspective on the regulatory issues regarding biosimilar use for psoriasis and psoriatic arthritis in 11 countries. Biological medications such as tumour necrosis factor (TNF)-a inhibitors are complex proteins. Biosimilars have identical amino-acid sequences to their originators but are not identical proteins as different manufacturing processes may result in subtly different proteins. Thus, biosimilars should be regarded as new medications with similar modes of action to the originators (the clue is in the name). The European Medicines Agency (EMA) has decided that similar efficacy between a biosimilar and the originator has to be demonstrated in a single disease in order to obtain marketing authorization across all of the indications of the originator. As an example, the biosimilar etanercept has received approval for psoriasis, psoriatic arthritis and rheumatoid arthritis, although the clinical trials on which approval was based were only done in rheumatoid arthritis. The article by Cohen et al. highlights that other regulatory authorities across the globe have had different and interesting approaches to biosimilar regulation. For the most part, the various national regulatory authorities have followed the lead of the Food and Drug Administration, the EMA and the World Health Organization recommendations on biosimilars. As highlighted in this article, there are concerns regarding switching therapies from originator to biosimilar. Recent randomized controlled data on switching biological therapy to biosimilars has shown noninferiority of biosimilars compared with originators in several diseases. However, these studies are not large enough to detect differences in the safety profile of these drugs. The Danish regulatory authorities were satisfied that there was sufficient data to recommend that all patients on infliximab and etanercept were to be switched to their biosimilar equivalent. The biosimilars currently licensed for psoriasis are TNF inhibitors. It is not unreasonable to assume that the excellent safety record of TNF inhibitors will also be seen with these biosimilar TNF inhibitors. The British Association of Dermatologists’ position paper on biosimilars recommends that patients commenced on these drugs be included in the U.K.’s psoriasis biologics interventions register (BADBIR), in order to assess their long-term efficacy and safety in a real-life setting. Dermatologists should distinguish clearly between the originator and the biosimilar when prescribing these therapies. Ideally, patients who are responding to an originator biological should not be switched to a biosimilar product. Financial pressures may make this ideal difficult to uphold. This global perspective on the regulatory issues concerning biosimilar drugs provides insight into national recommendations based on the data that are available now. The knowledge on biosimilars is expanding rapidly. Dermatologists should embrace usage of these medications as cheaper alternatives to originator therapies while being cognisant of the need to ensure that their long-term pharmacovigilance requirements are met.