Monoclonal Antibody Infliximab Biosimilar
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.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If classified as hormone-like product
Certain unmodified biotech proteins resembling hormones of heading 2937 shift out of Chapter 30 per exclusions.
If for other non-antisera immunologicals
If not strictly an antiserum or blood fraction, broader biotech immunologicals go to 3002.90.
If industrial enzyme production
Bulk biotech proteins for non-therapeutic industrial use classify as protein substances in Chapter 35.
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Import Tips & Compliance
• 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
Related Products under HTS 3002.12.00.90
Human Immunoglobulin G (IgG) Concentrate
A purified fraction of human blood plasma containing high levels of Immunoglobulin G antibodies, used therapeutically to treat primary immunodeficiencies and autoimmune disorders. It falls under HTS 3002.12.0090 as an immunological product derived from blood fractions, prepared for therapeutic use via biotechnological purification processes. This excludes simple blood products without specific immunological modification.
Cytomegalovirus (CMV) Hyperimmune Globulin
Hyperimmune plasma fraction enriched with CMV-specific antibodies for preventing CMV infection in transplant patients. Falls under HTS 3002.12.0090 as an other blood fraction/antisera prepared for prophylactic use through plasma fractionation. It meets the definition of immunological products from human blood.
Botulinum Toxin Type A Immune Globulin
Antitoxin derived from human plasma fractions containing antibodies against botulinum toxin, used to treat infant botulism. Classified in HTS 3002.12.0090 as an immunological blood fraction for therapeutic neutralization of toxins. It involves biotech purification of specific antisera.
Tetanus Immune Globulin (TIG)
Human blood fraction providing passive immunity against tetanus toxin for wound management. Under HTS 3002.12.0090 as other blood fraction antisera prepared for therapeutic use. Involves hyperimmunization and plasma fractionation.
Hepatitis B Immune Globulin (HBIG)
Plasma-derived antibodies specific to hepatitis B surface antigen for post-exposure prophylaxis in high-risk cases. Classifies in HTS 3002.12.0090 as an immunological blood fraction/antiserum. Biotechnological pooling and purification ensure specificity.
Varicella Zoster Immune Globulin (VZIG)
Human immune globulin enriched for varicella-zoster virus antibodies to prevent severe chickenpox in immunocompromised patients. HTS 3002.12.0090 for other specific antisera from blood fractions. Prepared via donor plasmapheresis and affinity purification.