Drugs / CHS-1420
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2021-02-17 | “FDA has accepted for review the 351(k) Biologics License Application (“BLA”) for CHS-1420” coherus.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07147257 | Feb → May 2025 | — | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02489227 | Aug 2015 → May 2016 | psoriasis | Coherus Oncology, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2021-12-20 | Coherus Oncology, Inc. | Regulatory Coherus Announces U.S. FDA Approval of YUSIMRY™ (adalimumab-aqvh) coherus.com ↗
Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) approved YUSIMRY™ (adalimumab-aqvh), formerly CHS-1420, a Humira® (adalimumab) biosimilar product. |
| 2021-02-17 | Coherus Oncology, Inc. | Regulatory Coherus BLA Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review coherus.com ↗
We are pleased to see the CHS-1420 BLA accepted for review as we continue to execute on our mission to increase patient access to important medicines and deliver substantial savings to the healthcare system, |
| 2017-08-28 | Coherus Oncology, Inc. | Results Coherus BioSciences Announces Positive Topline Results for Clinical Pharmacokinetic Bioequivalence Study for CHS-1420 (Humira® Biosimilar Candidate) versus European Marketed Humira in Healthy Subjects coherus.com ↗
The study met the criteria for clinical PK/BE on all prospectively defined endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC-0-last), and area under the time-concentration curve from first time point extrapolated to infinity (AUC-0-inf). |
| 2017-03-02 | Coherus Oncology, Inc. | Results Coherus Announces CHS-1420 Pharmacokinetic Clinical Bioequivalence Study Meets Primary Endpoint coherus.com ↗
Coherus BioSciences, Inc. (Nasdaq:CHRS), today announced that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a clinical pharmacokinetic (PK) bioequivalence study that compared CHS-1420 to Humira in healthy subjects. |
| 2017-01-10 | Coherus Oncology, Inc. | Results Coherus BioSciences Announces Positive Topline 24-Week Treatment Phase Three Results for CHS-1420 (HUMIRA® Biosimilar Candidate) in Patients with Psoriasis coherus.com ↗
At the start of Part 2 (Week 16), 80.3% of subjects in the CHS-1420 group and 77.5% of subjects in the HUMIRA group achieved PASI-75. |
| 2016-08-08 | Coherus Oncology, Inc. | Results Coherus BioSciences Announces Positive Topline Phase Three Results for CHS-1420 (Humira® Biosimilar Candidate) in Patients with Psoriasis coherus.com ↗
This study met its primary endpoint demonstrating similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at Week 12. |
| 2014-08-14 | Coherus Oncology, Inc. | Results Coherus Announces CHS-1420 (Investigational Adalimumab Biosimilar) Meets Primary Endpoint in Pivotal Pharmacokinetic Clinical Study coherus.com ↗
Coherus BioSciences, Inc. (“Coherus”) today announced that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a pivotal clinical pharmacokinetic (PK) similarity study that compared CHS-1420 to Humira® in healthy subjects. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CHS-1420 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02489227 ↗ |
| Route | Subcutaneous | “Dose of 40 mg will be subcutaneously administered” NCT07147257 ↗ |