Trastuzumab Monoclonal Antibody
Trastuzumab (Herceptin) is a humanized monoclonal antibody that inhibits HER2 protein, used in HER2-positive breast cancer therapy. Classified under HTS 3002.13.0010 as an unmixed monoclonal antibody product from biotechnological processes, supplied in bulk for pharmaceutical compounding. It regulates immunological processes via antibody targeting as defined in Chapter 30 notes.
Import Duty Rates by Country of Origin
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If in pre-measured vials for patient use
Dosage-form presentations for retail or clinical use move to 3002.15.
If complex mixture with other blood fractions
Products not purely unmixed monoclonal antibodies but combined with other fractions go to 3002.90.
If for US goods returned after biotech processing abroad
Articles assembled or processed abroad from US components may qualify for duty-free under 9802 if documented properly.
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Import Tips & Compliance
• Comply with USP <1046> cellular and tissue-based products standards if involving any cellular components
• Provide biotech origin certificates and endotoxin testing results to avoid quarantine at ports
• Label as 'not for retail sale' to prevent reclassification as consumer-packaged goods
Related Products under HTS 3002.13.00.10
Rituximab Monoclonal Antibody
Rituximab is a genetically engineered chimeric monoclonal antibody targeting CD20 on B-cells, used primarily for treating non-Hodgkin lymphoma and rheumatoid arthritis. It falls under HTS 3002.13.0010 as an unmixed immunological product consisting of monoclonal antibodies obtained via biotechnological processes, not put up in measured doses for retail sale. This classification applies to bulk pharmaceutical-grade preparations for further formulation.
Cetuximab Monoclonal Antibody
Cetuximab (Erbitux) targets EGFR for colorectal and head/neck cancer therapy, a chimeric monoclonal antibody. Bulk unmixed form imports under HTS 3002.13.0010 as a biotech immunological product per chapter note definitions. Excludes retail or dosed packings.
Infliximab Monoclonal Antibody
Infliximab (Remicade) is a chimeric monoclonal antibody neutralizing TNF-alpha for Crohn's disease and psoriasis. Classifies in HTS 3002.13.0010 for unmixed monoclonal immunological products from biotech, aligning with chapter's peptide/protein definition. Bulk for further processing.
Nivolumab Monoclonal Antibody
Nivolumab (Opdivo) human monoclonal antibody inhibits PD-1 for cancer immunotherapy applications. Bulk unmixed under HTS 3002.13.0010 as per immunological product notes for biotech proteins. Not in measured or retail forms.
Omalizumab Monoclonal Antibody
Omalizumab (Xolair) recombinant humanized monoclonal antibody binds IgE for severe asthma treatment. HTS 3002.13.0010 for unmixed monoclonal immunologicals from biotech processes. Bulk pharmaceutical grade.
Denosumab Monoclonal Antibody
Denosumab (Prolia) fully human monoclonal antibody inhibiting RANKL for osteoporosis. Classifies unmixed under HTS 3002.13.0010 per chapter immunological definitions. Bulk for formulation.