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Statement on FDA Release of Draft Interchangeability Guidance

Statement in Response to Final FDA Guidance on Nonproprietary Naming of Biological Products

Norwegian Study Shifts Support Toward Biosimilar Switching

Steven S. Sandoval Sr. Appointed as Chief Manufacturing Operations Officer

Statement on Introduction of CREATES Act to Support Access to Reference Product

Statement on Inclusion of Section 11, Biological Product Innovation in the FDA & NIH Workforce Authorities Modernization Act

Statement on the U.S. Food and Drug Administration (FDA) Approval of Celltrion’s Infliximab Biosimilar

Statement on the U.S. Food and Drug Administration (FDA) Draft Guidance on Biosimilar Labeling

Statement on the Food and Drug Administration (FDA) Arthritis Advisory Committee Meeting on Infliximab Biosimilar

House Committee Hearing Calls for More Clarity on Policies Facilitating Biosimilar Uptake