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Also known as MYL-1401A (Adalimumab)
MYL-1401A · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| MYL-1401A (Adalimumab) | EXPERIMENTAL | MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Humira® (Adalimumab) | ACTIVE_COMPARATOR | Humira® initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Name | Type | Description |
|---|---|---|
| MYL-1401A (Adalimumab) | BIOLOGICAL | MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Humira® (Adalimumab) | BIOLOGICAL | Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose |
Inclusion Criteria: 1. Subject has signed the informed consent form 2. Subject is aged 18 to 75 years, inclusive, at time of Screening 3. Subject has had moderate-to-severe chronic plaque psoriasis for at least 6 months * Subject has involved BSA ≥10%, PASI ≥12, and sPGA ≥3 (moderate) at Screen...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 11 | PHASE3 | JNJ-77242113, Ustekinumab, Guselkumab |
| Bristol-Myers Squibb Company | BMY | 14 | PHASE3 | Deucravacitinib |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Zasocitinib |
| Alumis Inc. | ALMS | 2 | PHASE3 | Envudeucitinib |
| Oruka Therapeutics, Inc. | ORKA | 4 | PHASE2 | ORKA-002, ORKA-001 |
| Can-Fite Biopharma Ltd | CANF | 1 | PHASE3 | Piclidenoson |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Ponesimod |
| Novartis AG Sponsored ADR | NVS | 4 | - | Secukinumab |
| Bausch Health Companies Inc. | BHC | 2 | - | Brodalumab |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-8644 |
MYL-1401A is an investigational monoclonal antibody developed by Viatris Inc. (ticker VTRS) as a proposed biosimilar to adalimumab. It is being studied in immunology, specifically for psoriasis, and has completed a Phase 3 comparability trial. It is not described as approved and remains in clinical development.
MYL-1401A is being developed for the treatment of psoriasis, an immune-mediated skin condition. Its Phase 3 study enrolled adults with psoriasis and also listed psoriatic arthritis among the conditions studied. The program is investigational, so the drug is not yet established as an approved psoriasis therapy.
MYL-1401A is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the Phase 3 comparability study of MYL-1401A. The asset is a monoclonal antibody candidate in the company's immunology pipeline.
MYL-1401A is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently listed as active. The completed study was randomized, double blind, and active controlled, enrolling 294 participants. The drug is investigational and has not been described as FDA approved.
MYL-1401A has been evaluated in the Phase 3 trial NCT02714322, titled MYL-1401A Efficacy and Safety Comparability Study to Humira. That study is completed, enrolled 294 participants, and was conducted in Bulgaria, Estonia, Hungary, Poland, Russia, and Ukraine. It studied psoriasis and psoriatic arthritis in adults aged 18 years and older.
MYL-1401A is also known as MYL-1401A (Adalimumab). It is a proposed adalimumab biosimilar, meaning it is developed as a comparable alternative to the reference adalimumab product rather than being the originator brand. Its Phase 3 study was designed as a comparability study against Humira.