On June 4, 2026, the U.S. FDA approved Lupin Limited's Ranluspec (ranibizumab-hkdz) as an interchangeable biosimilar referencing Genentech's Lucentis. This positions Ranluspec as the fourth interchangeable biosimilar of ranibizumab to receive FDA clearance.
Ranluspec is the only interchangeable ranibizumab biosimilar approved in both vial and pre-filled syringe presentations. Both formats are approved in the two strengths available for Lucentis: 0.3 mg and 0.5 mg.
The interchangeable designation allows pharmacy-level substitution without prescriber intervention, driving faster adoption. With four interchangeable options now available, pricing pressure on reference products will intensify.
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment requiring sophisticated biologics manufacturing. This creates opportunities for API suppliers, CDMOs, and technology transfer partners in complex biologics production.
