Drugs / PF-06438179
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT01844804 | May → Nov 2013 | — | Pfizer | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02222493 | Aug 2014 → Jun 2016 | rheumatoid arthritis | Pfizer | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2018-06-15 | Novartis Pharmaceuticals | Results Sandoz presents new long-term and switching data for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in rheumatoid arthritis novartis.com ↗
The research demonstrated that there were no clinically-meaningful differences from 30 to 54 weeks in terms of safety, efficacy and immunogenicity between patients with rheumatoid arthritis remaining on Sandoz infliximab and reference infliximab. |
| 2018-05-24 | Novartis Pharmaceuticals | Regulatory Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases novartis.com ↗
Sandoz, a Novartis division and the global leader in biosimilars, today announced that the European Commission (EC) has approved Zessly ® (infliximab) for use in Europe. |
| 2018-03-23 | Novartis Pharmaceuticals | Regulatory Sandoz receives positive CHMP opinion for proposed biosimilar infliximab novartis.com ↗ |
| 2017-12-13 | Pfizer | Regulatory FDA Approves New Pfizer Biosimilar pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product. |
| 2017-05-31 | Novartis Pharmaceuticals | Regulatory Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency novartis.com ↗
the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorization Applications for biosimilars to AbbVie's Humira ® (adalimumab) and Janssen's Remicade ® (infliximab) both of which are used to treat immunological diseases. |
| 2016-09-16 | Pfizer | Results Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Biosimilar to Remicade® (infliximab) pfizer.com ↗
The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology 20 (ACR20) response at Week 14. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-06-15 | Novartis Pharmaceuticals | Sandoz presents new long-term and switching data for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in rheumatoid arthritis novartis.com ↗ |
| 2018-05-24 | Novartis Pharmaceuticals | Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases novartis.com ↗ |
| 2018-03-23 | Novartis Pharmaceuticals | Sandoz receives positive CHMP opinion for proposed biosimilar infliximab novartis.com ↗ |
| 2017-12-13 | Pfizer | FDA Approves New Pfizer Biosimilar pfizer.com ↗ |
| 2017-05-31 | Novartis Pharmaceuticals | Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency novartis.com ↗ |
| 2016-09-16 | Pfizer | Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Biosimilar to Remicade® (infliximab) pfizer.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PF-06438179 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02222493 ↗ |
| Known as | GP1111 | “Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid...” PMID 31939063 ↗ Apr 20201“A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01).” PMID 29504427 ↗ Mar 2018 |
| Known as | PF-SZ-IFX | “Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid...” PMID 31939063 ↗ Apr 2020 |
| Route | Intravenous | “PF-06438179 will be administered by intravenous infusion” NCT02222493 ↗ |