Polyarticular juvenile idiopathic arthritis is a JIA subtype involving five or more joints in the first six months, often with chronic synovitis and potential long-term joint damage.
Dr. Reddy's said the FDA accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar to ORENCIA. The application covers an IV formulation for RA, PsA and pJIA.
The FDA has accepted for review Beren Therapeutics' NDA for adrabetadex in infantile-onset Niemann-Pick disease type C with a PDUFA date of August 17, 2026, and Dr. Reddy's BLA for a biosimilar to Orencia (abatacept).
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07553910 |
Tenosynovitis in Polyarticular and Oligoarticular Juvenile Idiopathic Arthritis |
NOT_YET_RECRUITING | |
| NCT07428551 |
Comparative Study of Leflunomide Plus Methotrexate Versus Methotrexate Monotherapy in Refractory Polyarticular Juvenile Idiopathic Arthritis Patients |
COMPLETED | PHASE4 |
| NCT07184450 |
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases |
RECRUITING | PHASE1 |
| NCT05754710 |
Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis |
RECRUITING | |
| NCT05411211 |
An Observational Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Pediatric Participants With Polyarticular Juvenile Idiopathic Arthritis (pJIA) |
COMPLETED | |
| NCT04018599 |
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS |
COMPLETED | PHASE1 |
| NCT02141984 |
Surveillance of Humira in Korean JIA Patients |
COMPLETED | |
| NCT00144625 |
Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA) |
COMPLETED | PHASE3 |
