Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?

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第一作者： Nadine,Kirsch-Stefan

第一单位： Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany. nadine.kirsch-stefan@pei.de.

作者： Nadine,Kirsch-Stefan ^[1] ; Elena,Guillen ^[2] ; Niklas,Ekman ^[3] ; Sean,Barry ^[4] ; Verena,Knippel ^[5] ; Sheila,Killalea ^[6] ; Martina,Weise ^[5] ; Elena,Wolff-Holz ^[7]

作者单位： Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany. nadine.kirsch-stefan@pei.de. ^[1] Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, Spain. ^[2] Finnish Medicines Agency, Helsinki, Finland. ^[3] Biosimilar Medicinal Products Working Party, EMA, Amsterdam, The Netherlands. ^[4] Biologics Working Party, EMA, Amsterdam, The Netherlands. ^[5] Health Products Regulatory Authority, Dublin, Ireland. ^[6] Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany. ^[7] Scientific Advice Working Party, EMA, Amsterdam, The Netherlands. ^[8] Federal Institute for Drugs and Medical Devices, Bonn, Germany. ^[9] Committee of Medicinal Products for Human Use, EMA, Amsterdam, The Netherlands. ^[10] Clinical Development and Medical Affairs, Biocon Biologics Ltd, Bengaluru, 560 100, India. ^[11]

主题词人类(Humans);抗体, 单克隆(Antibodies, Monoclonal);治疗结果(Treatment Outcome);药物批准(Drug Approval);随机对照试验(主题)(Randomized Controlled Trials as Topic)

DOI 10.1007/s40259-023-00631-4

PMID 37831324

发布时间 2023-10-23

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