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STADA and Xbrane launch ranibizumab in Europe

Martin Åmark

Ranibizumab biosimilar is being launched in major European markets.

Ranibizumab is the first product brought to market through a strategic collaboration between STADA and Xbrane Biopharma, marking Xbrane’s first commercial launch and STADA’s first co-development asset, in its growing biosimilars portfolio. Developed and manufactured solely in Europe, ranibizumab is the sixth biosimilar marketed in Europe by STADA, and the first to treat ophthalmologic conditions. With the introduction of ranibizumab in several European countries, partners STADA Arzneimittel AG and Xbrane Biopharma AB are offering European patients a cost-effective option to treat visual impairment in all the adult indications of the reference biologic, they state.

Shipments of the ranibizumab biosimilar, which is produced, filled, sterilized, and packaged entirely within Europe, have begun, and launch activities are underway, states Xbrane.

“We are proud to have worked with STADA to take this molecule, developed under the Xlucane name, from cell-line development to approval and manufacturing, based on our patented protein-expression system. Commercialization of our first biosimilar in Europe marks a major milestone in the evolution of our company,” says Martin Åmark, CEO of Xbrane.

The EU marketing authorization

The EU marketing authorization was based on a comprehensive comparative analytical assessment and a Phase 3 clinical study that demonstrated equivalent efficacy and comparable safety to the reference product. The Phase 3 clinical study involved 580 patients with wet age-related macular degeneration. The primary endpoint of the study was the change in best corrected visual acuity (BCVA) at week 8 compared to the baseline. This was met, as the adjusted treatment differences between the two products were within the predefined equivalence margin.

Photo of Martin Åmark: Xbrane