Pharmacokinetic equivalence and comparative safety, tolerability, and immunogenicity of Biocon's ustekinumab (Bmab-1200) with EU-approved and US-licensed reference ustekinumab in healthy subjects: results from the Study to Test pharmacokinetic BioEquivalence of BiosimiLar ustekinumab to SteLARa (STELLAR-1)

• Published in: Expert opinion on investigational drugs Vol. 34; no. 4; p. 349
• Main Authors: Ackroyd, Jonathan, Deodhar, Sarika S, Loganathan, Subramanian, Singh, Gursharan, Marwah, Ashwani, Kumar, Kuldeep, Panda, Jayanti, Athalye, Sandeep Nilkanth
• Format: Journal Article
• Language: English
• Published: England 03.04.2025
• Subjects: Adolescent; Adult; Area Under Curve; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatologic Agents - pharmacokinetics; Double-Blind Method; Female; Healthy Volunteers; Humans; Injections, Subcutaneous; Male; Middle Aged; Therapeutic Equivalency; United States; Ustekinumab - administration & dosage; Ustekinumab - adverse effects; Ustekinumab - pharmacokinetics; Young Adult; United States; safety; Ustekinumab; pharmacokinetics; Phase1; bioequivalence; immunogenicity; Bmab-1200

This study assessed the pharmacokinetics (PK) equivalence, safety, tolerability, and immunogenicity of Bmab-1200 versus the reference product ustekinumab (EU-approved and US-licensed Stelara). This 20-week, randomized, double-blind, three-arm, parallel-design, Phase-1 study enrolled healthy male and...