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.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If put up in measured doses or retail packings
Products in dosage forms like pre-filled syringes shift to heading 3002.15 for mixed or dosed immunological products.
If containing antigens or toxins
Immunological products mixed with antigens or toxins are classified under 3002.39, not pure monoclonal antibodies.
If classified as simple hormone peptides
Certain peptide-based immunological products may fall under Chapter 29 hormones if not qualifying as immunological per Chapter 30 notes.
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Import Tips & Compliance
• Verify FDA import alerts and biologics license applications; monoclonal antibodies require prior approval via IND or BLA
• Ensure cold chain documentation (2-8°C) and Certificate of Analysis confirming purity >95% and biotech origin
• Avoid misclassification as finished injectables; bulk form must not be in measured doses to qualify
Related Products under HTS 3002.13.00.10
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.
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.