Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06410293 · 4 trials · 3 indications
Cmax refers to maximum observed serum concentration of drug. The geometric coefficient of variation is expressed in percentage.
Area under the serum concentration curve from time 0 to end of dosing interval (tau), where dosing interval was once every two weeks. The geometric coefficient of variation is expressed in percentage.
ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T)
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 | EXPERIMENTAL | Subcutaneous (SC) injection given every other week |
| Treatment Arm 2 | ACTIVE_COMPARATOR | SC injection given every other week |
| PF-06410293 | EXPERIMENTAL | - |
| Adalimumab | ACTIVE_COMPARATOR | - |
| Adalimumab-US | ACTIVE_COMPARATOR | - |
| Adalimumab-EU | ACTIVE_COMPARATOR | Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose |
| A | EXPERIMENTAL | PF-06410293 |
| B | ACTIVE_COMPARATOR | Adalimumab-EU |
| C | ACTIVE_COMPARATOR | Adalimumab-US |
| Name | Type | Description |
|---|---|---|
| PF-06410293 | DRUG | SC injection |
| adalimumab | DRUG | SC injection |
| Adalimumab-US | BIOLOGICAL | Adalimumab-US will be administered as a single 40 mg, subcutaneous dose |
| Adalimumab-EU | BIOLOGICAL | Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose |
| Humira (adalimumab-EU) | BIOLOGICAL | 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe. |
| Humira (adalimumab-US) | BIOLOGICAL | 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe. |
Inclusion Criteria: * Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration. * Moderately to severely active RA based on local standard of care. Exclusion Criteria: -Evidence of untreated or inadequately treated latent or active TB.
Top 20 of 28 competitors
PF-06410293 is an investigational monoclonal antibody being studied for use in healthy subjects and in patients with active rheumatoid arthritis. It is being developed as a potential biosimilar to adalimumab (Humira) and is evaluated in combination with methotrexate for rheumatoid arthritis treatment.
PF-06410293 is a monoclonal antibody that targets tumor necrosis factor (TNF), similar to adalimumab. By binding to TNF, it is designed to neutralize its pro-inflammatory activity, which is relevant in autoimmune conditions like rheumatoid arthritis.
PF-06410293 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate this investigational biosimilar candidate for rheumatoid arthritis and other conditions.
PF-06410293 has completed Phase 1 and Phase 3 clinical trials. The Phase 1 studies were conducted in healthy subjects, while the Phase 3 trials evaluated the drug in patients with active rheumatoid arthritis. It remains an investigational agent and is not yet approved.
PF-06410293 has been studied in four completed trials: NCT01870986 and NCT02237729 (Phase 1 in healthy subjects), and NCT02480153 and NCT04230213 (Phase 3 in rheumatoid arthritis). These trials compared PF-06410293 with adalimumab, often in combination with methotrexate.
PF-06410293 is a proposed biosimilar to adalimumab (Humira), meaning it is designed to be highly similar to the reference product. Clinical trials have compared PF-06410293 directly with adalimumab to assess similarity in efficacy and safety, but it is not the same as the originator biologic.