[Biosimilars in rheumatology. Development and results of clinical trials].
BACKGROUND
This article presents the design of clinical trials for the development of biosimilars in the European Union and the United States, with special focus on inflammatory diseases.


METHODS
All information available in PubMed and the Internet relating to the clinical development of biosimilars in inflammatory rheumatic conditions (e.g. rheumatoid arthritis, psoriasis, psoriatic arthritis and ankylosing spondylitis) was collated. The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites were screened for guidelines on biosimilars.


RESULTS
More than 10 years ago the EMA began to publish guidelines for the development of biosimilars and several biosimilars have now been approved. In the USA the FDA has published guidance for the nonclinical and clinical development of biosimilars but until early 2015 no biosimilar had been approved.


CONCLUSIONS
Clinical trials aim to resolve uncertainties that may remain following nonclinical development regarding the similarity of the proposed biosimilar with the reference product. Pharmacokinetic and pharmacodynamic studies are essential for early clinical development and further phase 3 clinical studies. Factors to be considered in the clinical process include study population, design, endpoints, sample size, duration and analytical methods.
Abteilung Innere Medizin II, Rheumatologie, Klinische Immunologie, Osteologie, Physikalische Therapie und Sportmedizin, Leiterin klinisch osteologisches Schwerpunktzentrum (DVO), Schlosspark-Klinik, Akademisches Lehrkrankenhaus, Charité - Universitätsmedizin Berlin, Heubnerweg 2, 14059, Berlin, Deutschland. rieke.alten@schlosspark-klinik.de.
R
R
Alten
D018501:Antirheumatic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D005062:European Union; D006801:Humans; D017410:Practice Guidelines as Topic; D012216:Rheumatic Diseases / Q000188:drug therapy* / Q000378:metabolism; D012219:Rheumatology / Q000592:standards*; D014481:United States
D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals
European Medicines Agency; Inflammatory diseases; Rheumatic diseases; Therapeutic equivalence; United States Food and Drug Administration