Lupin clears major EU regulatory hurdle for biosimilar ranibizumab

Lupin Ltd. on Wednesday, December 17, said the European Medicines Agency’s (EMA's) drug advisory committee has adopted a positive opinion and recommended marketing authorisation for its biosimilar ranibizumab, marking a key regulatory milestone for the company in the European Union.

In an exchange filing, Lupin said the Committee for Medicinal Products for Human Use (CHMP) has backed the approval of the biosimilar, to be marketed as Ranluspec, in both vial and pre-filled syringe formats.

The recommendation will now be reviewed by the European Commission, which takes the final decision on granting EU-wide approval.

Ranibizumab is used in the treatment of several retinal disorders, including wet age-related macular degeneration, diabetic macular edema, retinal vein occlusion and proliferative diabetic retinopathy.

Thierry Volle, President EMEA and Emerging Markets, Lupin said, “This recognition underscores the quality of Lupin’s Biologics development and manufacturing as well as our relentless pursuit of affordable solutions
that transform patient care.”

The CHMP opinion was based on analytical similarity studies and data from a 600-patient global Phase III clinical trial conducted across the US, Europe, Russia and India.

Subject to final European Commission approval, Lupin’s biosimilar ranibizumab will be commercialised by Sandoz Group AG across the EU, excluding Germany. In France, the product will be marketed by Sandoz AG and Biogaran, under an earlier commercialisation agreement.

On Tuesday, December 16, the pharma major received a Voluntary Action Indicated (VAI) classification

in the Establishment Inspection Report (EIR) from the US FDA for its injectable facility in Nagpur, following an inspection conducted between September 8 and September 16, 2025.

Lupin reported a 73.34% year-on-year increase in net profit to ₹1,478 crore for the September quarter, up from ₹852.6 crore in the same period last year. Revenue from operations grew 24.2% year-on-year to ₹7,047.5 crore and EBITDA rose 74.7% to ₹2,341.7 crore, against ₹1,340.5 crore a year ago. The company’s EBITDA margin stood at 33.2%, up from 23.6% in the corresponding quarter of the previous year.

Shares of the company were trading 1.23% up at ₹2,116.40 as of 12:24 pm on Wednesday. The stock has gained 8.87% in the past six months.