Adalimumab Monoclonal Antibody from Japan
Adalimumab (Humira) is a fully human monoclonal antibody against TNF-alpha, treating autoimmune diseases like rheumatoid arthritis. It is imported as unmixed bulk under HTS 3002.13.0010, meeting the definition of immunological products directly regulating immune processes via biotech-derived proteins. Not in retail forms or measured doses.
Duty Rate — Japan → United States
15%
Rate breakdown
9903.04.6215%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter
9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 to this subchapter
9903.05.900%Articles of aluminum, of steel or of copper or derivative aluminum or steel articles; passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; parts of passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; medium- and heavy-duty vehicles; parts of medium- and heavy-duty vehicles; wood products; patented pharmaceutical articles; and semiconductor articles, as provided in subdivision (f) of U.S. note 52 to this subchapter
Import Tips
• Submit Form FDA 2877 for biologics and ensure biosimilar status if applicable for abbreviated pathways
• Monitor for stability data in import declarations to confirm non-degraded bulk product