Polypeptide, Protein, and Glycoprotein Hormones and Derivatives (NESOI)

The NESOI rule requires that 293719 be used only when no more specific heading applies. Somatotropin and its analogues belong under 293711; insulin and its salts under 293712. All other polypeptide, protein, and glycoprotein hormones — such as gonadotropins, erythropoietin, or thyrotropin — fall under 2937190000. When a novel biologic's classification is uncertain, a binding ruling request to CBP is the most reliable approach.

No — HTS classification is based on the chemical nature of the product, not its regulatory approval status. A biosimilar erythropoietin and the reference biologic both classify under 2937190000. However, biosimilar status is highly relevant to FDA admissibility: the product must reference an approved biosimilar application, and interchangeability designations affect substitution rights in the US market.