Rituximab Biosimilar Immunological Preparation from Japan
A mixed immunological product containing rituximab monoclonal antibodies used for treating non-Hodgkin lymphoma and rheumatoid arthritis. Classified under HTS 3002.14.0010 as it is an immunological product containing monoclonal antibodies, not put up in measured doses or retail packings. It consists of multiple components including the antibody and stabilizers for therapeutic use.
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
• Verify product contains monoclonal antibodies via certificate of analysis; ensure biotech origin documentation
• Comply with FDA biologics import requirements including lot release and proper cold chain validation
• Avoid misclassification as unmixed by confirming mixture of antibody with excipients; declare exact composition