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Monoclonal Antibody Infliximab Biosimilar from Germany

A recombinant chimeric monoclonal antibody targeting TNF-alpha, used for treating inflammatory conditions like rheumatoid arthritis. It qualifies under HTS 3002.90.52.50 as an immunological product directly involved in immune regulation, produced via biotechnological processes. Administered intravenously for therapeutic purposes.

Duty Rate — Germany → 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

Provide biotech origin certificates and stability data for FDA import review

Ensure single-use vial packaging documentation to meet sterile injectable standards

Differentiate from research-grade antibodies to avoid Chapter 98 exclusions