Comparison of the Pharmacokinetics, Safety, and Tolerability of the Autoinjector (AI) and Pre-Filled Syringe (PFS) of SB4 in Healthy Subjects.
autoinjector
bioequivalence
biosimilar
etanercept
pre-filled syringe
Journal
Drug design, development and therapy
ISSN: 1177-8881
Titre abrégé: Drug Des Devel Ther
Pays: New Zealand
ID NLM: 101475745
Informations de publication
Date de publication:
2020
2020
Historique:
received:
22
07
2019
accepted:
05
12
2019
entrez:
6
2
2020
pubmed:
6
2
2020
medline:
23
12
2020
Statut:
epublish
Résumé
SB4 is an etanercept biosimilar, approved by the European Commission (EC) and the US Food and Drug Administration (FDA) following a demonstration of equivalent efficacy and safety and comparable quality data to the reference product. This study aimed to demonstrate equivalent pharmacokinetic (PK) profiles, safety, and tolerability between SB4 autoinjector (AI) and SB4 pre-filled syringe (PFS). This was an open-label, two-period, two-sequence, single-dose, cross-over study to evaluate bioequivalence of PK profiles, safety, and tolerability between SB4 AI and PFS in healthy adults. Treatment periods were separated by 14 days resulting in a 35-day washout between investigational product (IP) administration in Periods 1 and 2. A total of 50 subjects were randomized: 24 subjects in Sequence I and 26 in Sequence II, and 6 subjects discontinued from the study. The primary PK endpoints including area under the concentration-time curve from time zero to infinity (AUC PK profiles showed that SB4 AI and PFS were bioequivalent in healthy subjects. Safety assessment was also comparable between the two treatments.
Identifiants
pubmed: 32021090
doi: 10.2147/DDDT.S224103
pii: 224103
pmc: PMC6955637
doi:
Substances chimiques
Biosimilar Pharmaceuticals
0
Etanercept
OP401G7OJC
Types de publication
Clinical Trial, Phase I
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
43-50Informations de copyright
© 2020 Shin et al.
Déclaration de conflit d'intérêts
Donghoon Shin, Younsoo Kim, and Ahra Go are employees of Samsung Bioepis Co., Ltd. The authors report no other conflicts of interest in this work.
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