Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 20 hours ago
- 1 min read
20/02/2026
Dr. Reddy’s announced that the US FDA had accepted for review its BLA for a proposed interchangeable biosimilar of ORENCIA® (Ref)
Dr. Reddy’s Laboratories announced that the US FDA had accepted for review its Biologics License Application (BLA) for an intravenous infusion formulation of DRL_AB, a proposed interchangeable biosimilar to ORENCIA® (abatacept; CTLA-4-Ig B7 Inhibitor), which had been submitted in December 2025
DRL_AB was intended to be administered as an IV infusion for adults with moderately-to-severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA) and for patients aged six years and older with moderately-to-severely active polyarticular juvenile idiopathic arthritis (pJIA)
The BLA was based on a robust data package supporting similarity to Orencia® IV infusion through the totality of evidence including pharmacokinetic data
Savara announced that the US FDA had filed for review the BLA for MOLBREEVI for the treatment of autoimmune PAP (Ref)
Savara announced that the US FDA had filed for review the BLA for MOLBREEVI (molgramostim) in patients with autoimmune pulmonary alveolar proteinosis (aPAP)
The FDA had granted Priority Review with a PDUFA action date of August 22, 2026
The company planned to submit Marketing Authorization Applications (MAAs) for MOLBREEVI for aPAP to the EMA and the MHRA by the end of Q1 2026
