A Randomized Pharmacokinetic Study in Healthy Male Subjects Comparing a High-concentration, Citrate-free SB5 Formulation (40 mg/0.4 ml) and Prior SB5 (Adalimumab Biosimilar)
Author:
Funder
Samsung Bioepis
Publisher
Springer Science and Business Media LLC
Subject
Immunology and Allergy,Rheumatology
Link
https://link.springer.com/content/pdf/10.1007/s40744-022-00471-8.pdf
Reference19 articles.
1. Kalliolias GD, Ivashkiv LB. TNF biology, pathogenic mechanisms and emerging therapeutic strategies. Nat Rev Rheumatol. 2016;12(1):49–62.
2. EMA. Humira®: EPAR—Product Information; Annex I, Summary of product characteristics. EMA; 2021.
3. FDA. Humira®: Prescribing Information. FDA; 2021.
4. Frampton JE. SB5: an adalimumab biosimilar. BioDrugs. 2018;32(5):507–10.
5. Shin D, Lee Y, Kim H, Kornicke T, Fuhr R. A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers. J Clin Pharm Ther. 2017;42(6):672–8.
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