Drugs / PF-06410293
PF-06410293
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02237729 | Sep 2014 → Mar 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01870986 | May 2013 → Feb 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT04230213 | Jan 2020 → Jun 2021 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT02480153 | Jun 2015 → Aug 2016 | rheumatoid arthritis | Pfizer | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-11-18 | Pfizer | Regulatory FDA Approves Pfizer’s Biosimilar, ABRILADA™ (adalimumab-afzb) for Multiple Inflammatory Conditions pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira ® (adalimumab), 1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. |
| 2017-01-05 | Pfizer | Results Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B538-02 Study for PF-06410293, a Potential Biosimilar to Humira®1 (adalimumab) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the comparative, confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12. |
All press releases naming this drug 2 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PF-06410293 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01870986 ↗ |
| Known as | Abrilada | “adalimumab (ADL) biosimilar PF-06410293 (ADL-PF: adalimumab-afzb; Abrilada®/Amsparity®/Xilbrilada®)” PMID 35304684 ↗ Mar 2022 |
| Known as | adalimumab-afzb | “adalimumab (ADL) biosimilar PF-06410293 (ADL-PF: adalimumab-afzb; Abrilada®/Amsparity®/Xilbrilada®)” PMID 35304684 ↗ Mar 20221“adalimumab biosimilar PF-06410293 (adalimumab-afzb)” PMID 38251497 ↗ Aug 2023 |
| Known as | ADL-PF | “adalimumab (ADL) biosimilar PF-06410293 (ADL-PF: adalimumab-afzb; Abrilada®/Amsparity®/Xilbrilada®)” PMID 35304684 ↗ Mar 2022 |
| Known as | Amsparity | “adalimumab (ADL) biosimilar PF-06410293 (ADL-PF: adalimumab-afzb; Abrilada®/Amsparity®/Xilbrilada®)” PMID 35304684 ↗ Mar 2022 |
| Known as | Xilbrilada | “adalimumab (ADL) biosimilar PF-06410293 (ADL-PF: adalimumab-afzb; Abrilada®/Amsparity®/Xilbrilada®)” PMID 35304684 ↗ Mar 2022 |
| Modality | Protein / enzyme biologic | “Biological: PF-06410293” NCT02480153 ↗ |
| Route | Subcutaneous | “administered by sub-cutaneous injection” NCT01870986 ↗ |