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Yamauchi has received research funding, consulting fees and\/or honoraria from AbbVie, Akros Pharma, Inc., Allakos, Almirall, Alumis, Amgen, AnaptysBio, Arcutis, Argenx, Aristea Therapeutics, ASLAN Pharmaceuticals, Biogen, Boehringer Ingelheim, Botanix Pharmaceuticals, Bristol-Myers Squibb, Cara Therapeutics, ChemoCentryx, Connect Biopharma, Dermavant Sciences, DICE Therapeutics, Dr. Reddy\u2019s Laboratory, EPI Health, Escalier, Evommune, Inc., Galapagos NV, Galderma USA, Glenmark Pharmaceuticals, Horizon Pharma, Hovione, Incyte Corporation, Janssen-Ortho, Leo Pharma, Lilly ICOS LLC, Medimmune, Nektar Therapeutics, Novartis Pharmaceuticals, Padagis, Pfizer, Q32 Bio, RAPT Therapeutics, Regeneron, Sanofi, Sik-Gel Technologies, Sun Pharma, UCB, and Xencor. Vincent Chow, Daniel T. Mytych, Muhan Zhou, and Waldemar Radziszewski are employees and stockholders of Amgen Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This switching study was developed in consultabr \/tion with the US FDA and aligned with the 2019 br \/FDA guidance entitled \u201cConsiderations in Dembr \/onstrating Interchangeability With a Reference br \/Product,\u201d which outlines the regulatory framebr \/work for establishing interchangeability between br \/a biosimilar and its RP. The study was conducted br \/at 85 centers in Canada, Estonia, Germany, br \/Latvia, Poland, and the USA (NCT05073315; br \/EudraCT 2021-000542-18; Figure 1) and was br \/conducted in accordance with International br \/Council for Harmonisation (ICH) Good Clinibr \/cal Practice (GCP) Guideline E6 (R1)\/Integrated br\/Addendum E6 (R2); 21 Code of Federal Regulabr \/tions Parts 50, 56, and 312; requirements for the br \/conduct of clinical studies as provided in the br \/EU Directive 2001\/20\/EC; the consensus ethical br \/principles derived from international guidelines br \/including the Declaration of Helsinki and Counbr \/cil for International Organizations of Medical br \/Sciences International Ethical Guidelines; and br \/all applicable laws and regulatory requirements. br \/The study protocol, the informed consent form, br \/and any accompanying materials provided to br \/the patients were reviewed and approved by an br \/institutional review board or independent ethics br \/committee at each study center (Table S1).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}