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. CONCLUSION: 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.
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. CONCLUSION: 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.
Entities:
Keywords:
European Medicines Agency; Inflammatory diseases; Rheumatic diseases; Therapeutic equivalence; United States Food and Drug Administration
Authors: Bruce E Strober; Katherine Armour; Ricardo Romiti; Catherine Smith; Paul W Tebbey; Alan Menter; Craig Leonardi Journal: J Am Acad Dermatol Date: 2012-02 Impact factor: 11.527
Authors: Jean Frédéric Colombel; William J Sandborn; Walter Reinisch; Gerassimos J Mantzaris; Asher Kornbluth; Daniel Rachmilewitz; Simon Lichtiger; Geert D'Haens; Robert H Diamond; Delma L Broussard; Kezhen L Tang; C Janneke van der Woude; Paul Rutgeerts Journal: N Engl J Med Date: 2010-04-15 Impact factor: 91.245
Authors: M Rinaudo-Gaujous; S Paul; E D Tedesco; C Genin; X Roblin; L Peyrin-Biroulet Journal: Aliment Pharmacol Ther Date: 2013-09-03 Impact factor: 8.171
Authors: William J Sandborn; Brian G Feagan; Colleen Marano; Hongyan Zhang; Richard Strauss; Jewel Johanns; Omoniyi J Adedokun; Cynthia Guzzo; Jean-Frederic Colombel; Walter Reinisch; Peter R Gibson; Judith Collins; Gunnar Järnerot; Toshifumi Hibi; Paul Rutgeerts Journal: Gastroenterology Date: 2013-06-02 Impact factor: 22.682
Authors: Jan Visser; Isabel Feuerstein; Thomas Stangler; Timo Schmiederer; Cornelius Fritsch; Martin Schiestl Journal: BioDrugs Date: 2013-10 Impact factor: 5.807
Authors: Mohammed A Omair; Rana Almadany; Maha A Omair; Hanan Al Rayes; Haya M Almalag; Aws Alshamsan Journal: Saudi Pharm J Date: 2021-12-21 Impact factor: 4.330