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Xbrane Talks Launch Plans After Initiating US Xlucane Study

Executive Summary

Having initiated the US clinical trial for its Xlucane (ranibizumab) biosimilar, Xbrane describes the competitive situation for the ophthalmology drug in the US and Europe as “promising”, detailing plans to launch in the second quarter of 2022. The Swedish biosimilars specialist also offers updates on the rest of its pipeline.

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Xbrane Expects Its Lucentis Rival To Capture A Quarter Of Volumes

Xbrane, which has just kicked off a Phase III study for its Xlucane ranibizumab biosimilar to Lucentis, has set a target of ranibizumab generating annual sales of €350m within three years of launch, based on capturing a quarter of the Lucentis market by volume in both Europe and the US.

Xbrane Set To Initiate Xlucane Study In US

Xbrane Biopharma has announced further progress for its lead biosimilar candidate, Xlucane (ranibizumab), with the FDA and the Central Ethics Committee in the US accepting the firm’s investigational new drug application, allowing the company’s ‘Xplore’ Phase III trial for the ophthalmology drug to begin.

Xbrane ‘shifts focus’ to biosimilar portfolio

Xbrane Biopharma has announced that it is shifting its full strategic focus to its biosimilars pipeline in the wake of striking a global co-development deal with Stada for its Xlucane (ranibizumab) rival to Lucentis. The strategic shift means that the Swedish firm will abandon, at least for the time being, development efforts on generic long-acting injectables beyond its existing Spherotide (triptorelin) product.

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