Lupin Achieves Key CHMP Milestone for Ranibizumab Biosimilar

Lupin Limited, a global pharma company, announced today that the Committee for Medicinal Products to Human Use (CHMP) of the European Medicines Agency had given a positive opinion.

The opinion suggests that Lupin marketing authorization be granted on its biosimilar ranibizumab, Ranluspec, both vial and pre-filled syringe. This is a big milestone of the company regarding the regulation in Europe.

Ranibizumab is a recombinant humanized monoclonal antibody, IgG1, which targets the vascular endothelial growth factor A (VEGF -A).

It is used in the treatment of severe retinal diseases, including wet age-related macular degeneration, post-retinal vein occlusion macular edema, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization. The acceptance of Lupin ranibizumab biosimilar would enable more people in the EU to gain access to these treatments.

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A solid comparability package contributes to the recommendation of the CHMP. It includes analytical similarity tests in detail analysis and a global Phase III trial on 600 patients with neovascular AMD. The research was conducted in the US, EU, Russia and India and revealed that the biosimilar is clinically equivalent with the reference drug.

Thierry Volle, President, EMEA and Emerging Markets, Lupin, was quoted saying, we are delighted with the positive opinion of CHMP. It demonstrates the standard of our development and production of biologics, and reiterates our purpose to affordable solutions that transform the way patients are treated.

The opinion will now be taken to the European Commission to be reviewed. A positive vote by the Commission will allow a centralized marketing authorization in which all EU member countries will be covered. Sandoz Group AG has settled on commercializing the biosimilar across the EU, except Germany. In France, Sandoz AG and Biogaran will collaborate in commercializing it.