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Infliximab biosimilar GP1111: a review of 5 years' post-approval ...

Introduction: Infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha, and GP1111 (Zessly®, Sandoz) is the most recently approved infliximab biosimilar in Europe. We reviewed the approval process and key evidence for GP1111, focusing primarily on the indications of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Areas covered: This narrative review ...

Full article: Infliximab biosimilar GP1111: a review of 5 years' post ...

Infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha, and GP1111 (Zessly®, Sandoz) is the most recently approved infliximab biosimilar in Europe. We reviewed the approva...

PF-06438179/GP1111: An Infliximab Biosimilar - PMC

PF-06438179/GP1111 (Zessly ®; Ixifi ®) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic ...

A Randomized, Double-Blind Study Comparing PF-06438179/GP1111, a ...

Background/Purpose: This double-blind, randomized study evaluated efficacy, safety and immunogenicity of PF‑06438179/GP1111, a potential infliximab biosimilar, vs infliximab sourced from the EU (infliximab-EU) in patients (pts) with moderate to severe active RA with inadequate response to MTX and ≤2 doses of 1 non-depleting, non-infliximab biologic. We report results after the first 30 wks ...

12 pcs M&G GP-1111 0.7mm Roller Gel Pen Retractable Smooth Writing (Blue)

About this item High performance ink technology combines the best qualities of liquid and gel ink for a super-smooth writing experience. It doesn't matter if you're at school, at work, in the office, or need to write at home, Baoke Gel Fine Point Pens are comfortable, flow smoothly You can rely on our gel pen, rollerball pens, proven to be the longest lasting gel ink pen, with an extra ...

The 'totality-of-the-evidence' approach in the development of PF ...

Abstract 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 ...

A randomized controlled trial comparing PF-06438179/GP1111 (an ...

A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy

Randomised, double-blind, phase III study comparing the infliximab ...

Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54

PF-06438179/GP1111: An Infliximab Biosimilar - PubMed

Abstract PF-06438179/GP1111 (Zessly ®; Ixifi ®) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis ...

PF-06438179/GP1111: An Infliximab Biosimilar | BioDrugs - Springer

PF-06438179/GP1111 (Zessly ®; Ixifi ®) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic ...

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