Two new interchangeable Lucentis biosimilars — Lupin's Ranluspec and Formycon/Bioeq's Nufymco — have received FDA approval, while Xbrane's Lucamzi is under review with an October target date. The Lucentis global market was valued at $630 million in 2024.
The FDA has approved an expanded label for Sandoz's aflibercept biosimilar Enzeevu to include multiple retinal indications beyond its original approval for neovascular age-related macular degeneration. The product is expected to launch in the US in Q4 2026.
CStone Pharmaceuticals has received FDA clearance for its IND application to initiate a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGFA, and CTLA-4, in patients with advanced solid tumors across nine cancer indications.
