Lupin Receives European Commission Approval For Biosimilar Ranibizumab

Global pharma major Lupin Ltd has secured European Commission approval for its biosimilar ranibizumab, marketed as Ranluspec. The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Ranibizumab is widely prescribed for retinal disorders, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), and macular edema following retinal vein occlusion (RVO).  

Key Highlights  

• European Commission grants approval for Lupin’s biosimilar ranibizumab, Ranluspec  
• CHMP had earlier issued a positive opinion recommending marketing authorization  
• Indications include AMD, DME, PDR, RVO, and choroidal neovascularization  
• Ranluspec to be available in both vial and pre-filled syringe formats  
• Sandoz Group AG to oversee commercialization across Europe and select regions  
• Approval strengthens Lupin’s footprint in ophthalmology and biosimilars markets  

Strategic Impact  
The approval represents a significant regulatory milestone for Lupin, enhancing its presence in the European biosimilars market. Partnering with Sandoz for commercialization ensures strong distribution and market penetration. Analysts highlight that Ranluspec will provide a cost-effective alternative to branded ranibizumab, supporting wider patient access while reinforcing Lupin’s global growth strategy in specialty therapies.  

Sources: Lupin Press Release, CNBC-TV18, Ophthalmology Times Europe