Orencia is the brand name of abatacept, a selective T-cell costimulation modulator used in autoimmune and transplant-related settings. It is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and prophylaxis of acute graft-versus-host disease in specified patients. The FDA first approved Orencia on December 23, 2005.
Bristol Myers Squibb said 2025 revenue was flat as a 17% increase in growth-portfolio sales offset a 15% decline in legacy drugs. The company expects legacy sales to fall another 12-16% in 2026, with newer products such as Opdivo, Reblozyl and Breyanzi supporting results.
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.
Healthcare sector surged 10% since Q4 2025, outpacing all S&P 500 sectors as investors rotate from tech to pharmaceutical value plays. Major drugmakers demonstrate resilience following Medicare price negotiations implementation.
Bristol Myers Squibb's growth portfolio increased 17% in 2025, partially offsetting a 15% decline in legacy products facing generic competition. The company's stock gained 11.4% in the past month on strong fourth-quarter results.
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).
Dr. Reddy's Laboratories secures FDA acceptance for DRL-AB, the first abatacept biosimilar application in the U.S., targeting a market worth $3.7 billion annually and positioning the company for first-mover advantage.
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.
Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar application targeting Bristol-Myers Squibb's Orencia, marking the first U.S. application for an off-patent version of the arthritis treatment that generated $2.7 billion in 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT03411850 |
Sjogrens Syndrome Measured by Ultrasound |
UNKNOWN | PHASE2 |
| NCT02600468 |
Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg |
COMPLETED | |
| NCT02600455 |
Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL |
COMPLETED | |
| NCT02466581 |
Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity |
UNKNOWN | PHASE4 |
| NCT01694693 |
Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study |
WITHDRAWN | |
| NCT01638715 |
A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action |
COMPLETED | PHASE4 |
| NCT01491815 |
Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction |
UNKNOWN | PHASE4 |
