PMID- 33765358
OWN - NLM
STAT- MEDLINE
DCOM- 20220222
LR  - 20220222
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Print)
IS  - 2160-763X (Linking)
VI  - 10
IP  - 10
DP  - 2021 Oct
TI  - Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of 
      PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing 
      Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects.
PG  - 1166-1173
LID - 10.1002/cpdd.939 [doi]
AB  - This open-label, single-dose, randomized, parallel-group, 2-arm phase 1 
      bioequivalence (BE) study assessed the pharmacokinetics (PK), safety, and 
      tolerability of PF-06410293 (ADL-PF), an adalimumab (ADL) biosimilar, following 
      administration by prefilled pen (PFP) or prefilled syringe (PFS). A total of 164 
      healthy adult subjects were randomized (1:1) to receive ADL-PF (40 mg 
      subcutaneously) in the lower abdomen or upper anterior thigh by PFS or PFP; 163 
      subjects were included in the primary PK analysis. The concentration-time 
      profiles of the ADL-PF PFS and PFP treatment arms were similar. The 90% 
      confidence intervals for the test/reference ratios of the primary end points 
      (area under the serum concentration-time profile from time 0 to 2 weeks after 
      dosing and maximum observed serum concentration) fell within the 80.00%-125.00% 
      prespecified margin for BE. Comparable numbers of subjects experienced adverse 
      events (AEs) between treatment groups, and injection-site pain was similar at all 
      times and for the 2 injection-site locations. This study demonstrated the BE of 
      ADL-PF following subcutaneous administration using either a PFS or PFP device. 
      ADL-PF by PFS or PFP injection was well tolerated, with the distribution of AEs, 
      including injection-site reactions, being similar between treatment arms.
CI  - (c) 2021 Pfizer Inc. Clinical Pharmacology in Drug Development published by Wiley 
      Periodicals LLC on behalf of American College of Clinical Pharmacology.
FAU - Cox, Donna S
AU  - Cox DS
AD  - Pfizer Inc, Collegeville, Pennsylvania, USA.
FAU - Alvarez, Daniel F
AU  - Alvarez DF
AD  - Pfizer Inc, Collegeville, Pennsylvania, USA.
FAU - Bock, Amy E
AU  - Bock AE
AD  - Pfizer Inc, Cambridge, Massachusetts, USA.
FAU - Cronenberger, Carol L
AU  - Cronenberger CL
AD  - Pfizer Inc, Collegeville, Pennsylvania, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02572245
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210325
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (PF-06410293)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/*administration & dosage/adverse effects/*blood
MH  - Adult
MH  - Biosimilar Pharmaceuticals/*administration & dosage/adverse effects/*blood
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Injection Site Reaction/diagnosis
MH  - Injections, Subcutaneous/methods
MH  - Male
MH  - Middle Aged
MH  - *Syringes
PMC - PMC8518774
OTO - NOTNLM
OT  - PF-06410293
OT  - adalimumab
OT  - bioequivalence
OT  - pharmacokinetics
COIS- Donna Cox, Daniel Alvarez, and Amy Bock are employees of and hold stock or stock 
      options from Pfizer. Carol Cronenberger was an employee of and held stock or 
      stock options from Pfizer at the time the study was conducted.
EDAT- 2021/03/26 06:00
MHDA- 2022/02/23 06:00
PMCR- 2021/10/15
CRDT- 2021/03/25 17:40
PHST- 2020/11/20 00:00 [received]
PHST- 2021/02/23 00:00 [accepted]
PHST- 2021/03/26 06:00 [pubmed]
PHST- 2022/02/23 06:00 [medline]
PHST- 2021/03/25 17:40 [entrez]
PHST- 2021/10/15 00:00 [pmc-release]
AID - CPDD939 [pii]
AID - 10.1002/cpdd.939 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2021 Oct;10(10):1166-1173. doi: 10.1002/cpdd.939. Epub 
      2021 Mar 25.