USFDA accepts for review Dr Reddy’s biologics license application for Orencia biosimilar DRL_AB Swati Bharadwaj Hyderabad: Dr Reddy’s Laboratories Ltd said the US Food and Drug Administration accepted for review its 351(k) Biologics License Application for DRL_AB, a proposed interchangeable biosimilar to Orencia (abatacept) that is administered as an intravenous infusion.
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, the Hyderabad-based company said.
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.
Dr Reddy’s said the application was submitted in December 2025 and 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.
“We are proud to be the first to submit a BLA for an abatacept biosimilar, which marks a significant milestone in our mission to increase patient access to critical, high-quality biologic therapies,” said Milan Kalawadia, CEO, North America at Dr Reddy’s.
He added 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.
Elaborating on the clinical milestones for the programme, the company said 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.
