PMID- 31223341
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1756-283X (Print)
IS  - 1756-2848 (Electronic)
IS  - 1756-283X (Linking)
VI  - 12
DP  - 2019
TI  - The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, 
      an infliximab biosimilar, and in support of its use in all indications of the 
      reference product.
PG  - 1756284819852535
LID - 10.1177/1756284819852535 [doi]
LID - 1756284819852535
AB  - The 'totality-of-the-evidence' biosimilarity concept requires that sufficient 
      structural, functional, nonclinical, and clinical data are acquired in a stepwise 
      manner, to demonstrate that no clinically meaningful differences in quality, 
      safety, or efficacy are observed compared with the reference product. We describe 
      the totality of the evidence for PF-06438179/GP1111 (PF-SZ-IFX; IXIFI 
      [infliximab-qbtx]/Zessly(R)) that supported its approval as an infliximab (IFX) 
      biosimilar for all eligible indications of reference IFX (ref-IFX; Remicade(R)) in 
      Europe and in the US. Analytical similarity involving in vitro assays capable of 
      distinguishing structural or functional differences between PF-SZ-IFX and ref-IFX 
      formed a foundation for the biosimilarity exercise. Differences identified in 
      N-glycosylation and charge heterogeneity were found not to impact the results in 
      in vitro biological assays reflective of the pharmacology underlying the 
      mechanisms of action (tumor necrosis factor binding, reverse signaling, 
      antibody-dependent cell-mediated cytotoxicity and complement-dependent 
      cytotoxicity) of IFX across disease indications. Similarity was assessed in a 
      comparative clinical pharmacokinetic study and in a clinical efficacy and safety 
      study in patients with rheumatoid arthritis, where therapeutic equivalence 
      between PF-SZ-IFX and ref-IFX provided confirmatory evidence of biosimilarity, 
      and, when coupled with the analytical similarity already established, supported 
      extrapolation to all eligible disease indications of ref-IFX.
FAU - McClellan, Joseph E
AU  - McClellan JE
AD  - Pfizer Inc., Biosimilars Development, 235 East 42nd Street, New York, NY 10017, 
      USA.
FAU - Conlon, Hugh D
AU  - Conlon HD
AD  - Analytical Research and Development, Pfizer Inc., Andover, MA, USA.
FAU - Bolt, Michael W
AU  - Bolt MW
AD  - Drug Safety Research and Development, Pfizer Inc., Cambridge, MA, USA.
FAU - Kalfayan, Vatche
AU  - Kalfayan V
AD  - Clinical Operations, Pfizer Inc., San Francisco, CA, USA.
FAU - Palaparthy, Rameshraja
AU  - Palaparthy R
AD  - Clinical Pharmacology, Pfizer Inc., San Diego, CA, USA.
FAU - Rehman, Muhammad I
AU  - Rehman MI
AD  - Clinical Development, Pfizer Inc., Andover, MA, USA.
FAU - Kirchhoff, Carol F
AU  - Kirchhoff CF
AD  - Global Technology Services, Biotechnology and Aseptic Sciences Group, Pfizer 
      Inc., Chesterfield, MO, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20190613
PL  - England
TA  - Therap Adv Gastroenterol
JT  - Therapeutic advances in gastroenterology
JID - 101478893
PMC - PMC6566480
OTO - NOTNLM
OT  - PF-06438179/GP1111
OT  - biosimilar
OT  - extrapolation
OT  - infliximab
OT  - totality of the evidence
COIS- Conflict of interest statement: Joseph E. McClellan, Hugh D. Conlon, Michael W. 
      Bolt, Vatche Kalfayan, Rameshraja Palaparthy, Muhammad I. Rehman, and Carol F. 
      Kirchhoff are employees of and hold stock in Pfizer Inc.
EDAT- 2019/06/22 06:00
MHDA- 2019/06/22 06:01
PMCR- 2019/06/13
CRDT- 2019/06/22 06:00
PHST- 2018/12/20 00:00 [received]
PHST- 2019/04/25 00:00 [accepted]
PHST- 2019/06/22 06:00 [entrez]
PHST- 2019/06/22 06:00 [pubmed]
PHST- 2019/06/22 06:01 [medline]
PHST- 2019/06/13 00:00 [pmc-release]
AID - 10.1177_1756284819852535 [pii]
AID - 10.1177/1756284819852535 [doi]
PST - epublish
SO  - Therap Adv Gastroenterol. 2019 Jun 13;12:1756284819852535. doi: 
      10.1177/1756284819852535. eCollection 2019.