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Sweden’s Xbrane Lays Out Ranibizumab Ambitions

As Key Biosimilar Trial Affected By COVID-19

 
• By Dean Rudge

Through a partnership with Stada, Sweden’s Xbrane is looking to introduce a biosimilar to Lucentis in major developed markets, including the EU and the US, where the hunt for a commercialization partner continues.

Eye
Xbrane is eyeing the considerable size of the anti-VEGF market for its biosimilar ranibizumab candidate • Source: Shutterstock

Sweden’s Xbrane Biopharma says it is “on track” to obtain an EU marketing authorization for the firm’s Xlucane (ranibizumab) proposed biosimilar to Lucentis before the expiry of patents shielding the blockbuster eye-disease treatment in July 2022, despite challenges posed by the accelerating COVID-19 crisis.

In the firm’s annual report published on 16 April, the biosimilars and long-acting injectables specialist outlines several key goals in the next 12 months, among them wrapping up and publishing top-line data from the company’s “Xplore” Phase III clinical trial to support the filing of marketing authorization applications for

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More from Products

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

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Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By Dean Rudge

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.