Monoclonal Antibody Infliximab Biosimilar from Japan
A biotechnologically produced chimeric monoclonal antibody targeting TNF-alpha, used to treat inflammatory conditions like Crohn's disease. It qualifies under HTS 3002.12.0090 as an immunological product (per chapter note) obtained via biotech processes from blood fraction-inspired cell cultures. This covers modified proteins regulating immune processes.
Duty Rate — Japan → United States
15%
Rate breakdown
9903.04.6215%Pharmaceuticals: patented pharma from JP/EU/KR/CH/LI — 15% floor rate
9903.05.860%Universal product exemption (U.S. note 52(b))
9903.05.900%Articles already subject to Section 232 (steel/aluminum/copper + derivatives, autos + parts, wood, medium/heavy vehicles + parts, semiconductors, patented pharma) — U.S. note 52(f)
Import Tips
• Submit IND or BLA documentation proving therapeutic immunological function to justify Chapter 30 classification
• Monitor for biotech origin certification; declare purity levels >95% to avoid Chapter 35 peptide reclassification