IMMGOLIS

FDA Approves IMMGOLIS (Golimumab-sldi) from Accord Biopharma Inc. Under Type 5 BLA

Accord Biopharma Inc. has secured FDA approval for IMMGOLIS (Golimumab-sldi), an original Type 5 Biologics License Application (BLA761452) as a new formulation or new manufacturer. This approval, granted on May 15, 2026, introduces three distinct injectable formulations, enhancing supply chain diversification and market competition for Golimumab-sldi. Procurement and business development teams should evaluate this new entrant for strategic sourcing and market positioning.