FDA Accepts Dr Reddy's Application for Orencia Biosimilar DRL-AB

The US Food and Drug Administration accepted for review Dr Reddy's Laboratories' 351(k) Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) that is administered as an intravenous infusion. The application was submitted in December 2025, making Dr Reddy's the first to submit a BLA for an abatacept biosimilar.

If approved, DRL-AB would be indicated for adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis, and patients aged 6 years and older with moderately to severely active polyarticular juvenile idiopathic arthritis.

Abatacept is a selective co-stimulation modulator that inhibits T-cell activation by binding to CD80 and CD86, blocking interaction with CD28, a signal required for full T-lymphocyte activation.

The application is supported by a "totality of evidence" package intended to demonstrate similarity to Orencia IV for infusion, including pharmacokinetic data along with analytical and clinical studies. The CEO of North America at Dr Reddy's stated the company was looking forward to working with the FDA to bring the in-house developed biosimilar to the US market as a cost-effective alternative for patients and healthcare providers.

The Phase 1 study (AB-01-003) met pharmacokinetic similarity objectives and showed comparable safety and immunogenicity profiles versus Orencia. A pivotal Phase 3 study (AB-01-004) comparing the efficacy and safety of DRL-AB with Orencia is currently underway.