
Biotechnologicals are an invaluable resource in the treatment of patients with inflammatory rheumatic diseases (IRD) non-responsive or intolerant to conventional therapies. However, they are the main driver for increase in direct costs and represent a significant economic burden to healthcare systems worldwide. Since biosimilars are similar and more affordable versions of previously licenced biotechnologicals, they are expected to contribute to healthcare system sustainability and reduce inequities in treatment access. The landmark approval of CT-P13 as the first infliximab biosimilar paved the way for new infliximab but also etanercept, adalimumab and rituximab biosimilars. In Europe, North America and some countries of Asia, development is strictly regulated and only those presenting a totality-of-evidence dossier with highly similar physicochemical, biological and clinical performances are endorsed by regulatory agencies as biosimilars. The current article addresses the importance of biosimilar medicines in the treatment of IRD, as well as their innovative development and regulatory pathways, clinical evidence of similarity and challenges that may undermine their widespread use and success.
Biosimilar, Adalimumab, Extrapolation, Antibodies, Monoclonal, Switch, Infliximab, Etanercept, Drug Development, Rheumatology, Antirheumatic Agents, Rheumatic Diseases, SB4, Animals, Humans, Rheumatic disease, Interchangeability, Rheumatic Fever, Rituximab, Biosimilar Pharmaceuticals, CT-P13
Biosimilar, Adalimumab, Extrapolation, Antibodies, Monoclonal, Switch, Infliximab, Etanercept, Drug Development, Rheumatology, Antirheumatic Agents, Rheumatic Diseases, SB4, Animals, Humans, Rheumatic disease, Interchangeability, Rheumatic Fever, Rituximab, Biosimilar Pharmaceuticals, CT-P13
| selected citations These citations are derived from selected sources. This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | 15 | |
| popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network. | Top 10% | |
| influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Average | |
| impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Top 10% |
