Unmixed Infliximab Biosimilar
Infliximab biosimilar is a monoclonal antibody binding TNF-alpha, used for inflammatory conditions like rheumatoid arthritis. HTS 3002.13.0090 covers it as an unmixed, biotech-derived immunological product not in retail form. It qualifies per chapter notes as a protein regulating immunological processes.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If specific statistical suffixes if applicable, but generally 'other'
Finer breakdowns exist but '90' catches unspecified immunological products.
If treated as enzymes or peptidases rather than immunological
Some protein products may shift to 3504 if primary function is enzymatic, not immune regulation.
If prepared as finished ostomy appliances
Chapter 3006 covers identifiable medical appliances, not bulk immunological actives.
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Import Tips & Compliance
• Provide biotech manufacturing details and sequence data to distinguish from chemical synthetics under Chapter 29
• Comply with CBP biotech import requirements, including advance notice for high-value shipments over $10,000
• Label clearly as 'unmixed' to prevent reclassification; dilution in water still counts as unmixed per chapter notes
Related Products under HTS 3002.13.00.90
Unmixed Monoclonal Antibody Bevacizumab
Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor (VEGF) for therapeutic use in cancer treatment. It falls under HTS 3002.13.0090 as an unmixed immunological product not put up in measured doses or retail packaging, directly involved in regulating immunological processes. This classification applies to bulk biotech-derived antibodies for further pharmaceutical processing.
Bulk Rituximab Immunological Product
Rituximab is a chimeric monoclonal antibody targeting CD20 on B-cells, used in lymphoma and autoimmune disease therapy. Classified under HTS 3002.13.0090 as an unmixed immunological product obtained via biotechnological processes, supplied in bulk for formulation. It regulates immunological processes as defined in chapter notes.
Bulk Trastuzumab Emtansine Conjugate
Trastuzumab emtansine is an antibody-drug conjugate (ADC) with monoclonal antibody linked to chemotherapy agent for HER2-positive breast cancer. Classifies as unmixed immunological product in HTS 3002.13.0090 per notes covering antibody conjugates. Bulk form excludes retail packaging.
Adalimumab High-Concentration Solution
Adalimumab is a fully human monoclonal antibody against TNF for autoimmune diseases like psoriasis. As an aqueous solution of unmixed product, it qualifies under HTS 3002.13.0090 per chapter notes treating dissolved unmixed products similarly. Bulk for further dilution.
Bulk Pembrolizumab
Pembrolizumab is a PD-1 inhibitor monoclonal antibody for immuno-oncology applications. Classifies in HTS 3002.13.0090 as unmixed biotech immunological product regulating immune checkpoint processes. Not for retail sale.
Nivolumab Drug Substance
Nivolumab drug substance is bulk PD-1 blocking antibody for melanoma and lung cancer therapy. HTS 3002.13.0090 for unmixed immunological products via biotech processes. Meets definition of antibody regulating immunology.