Clinical trial development for biosimilars.

摘要: Abstract Objectives Discuss issues regarding clinical trial design for the development of biosimilars in European Union and United States, with special focus on monoclonal antibodies used treatment inflammatory diseases. Methods A search Internet as well PubMed was conducted through June 2014 information related to using keywords biosimilar, rheumatoid arthritis, juvenile idiopathic psoriasis, psoriatic Crohn’s disease, ulcerative colitis, ankylosing spondylitis. The Medicines Agency (EMA) US Food Drug Administration (FDA) websites were searched biosimilar guidelines. Results EMA began issuing draft guidelines almost a decade ago has approved numerous biosimilars. FDA issued guidances providing stepwise considerations nonclinical but yet approve under this pathway. Conclusions Clinical trials aim resolve uncertainties that may remain following similarity proposed reference product. Pharmacokinetic pharmacodynamic studies form backbone early serve inform phase 3 development. Factors be considered include study population, design, end points, sample size, duration, analytical methods.