1. Generics Bulletin
  2. >>Products

Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar

Complete Response Letter Flags Two Issues, Although No More Clinical Trials Required

 
• By Dean Rudge

Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.

Denied
• Source: Alamy

Xbrane Biopharma has assembled a task force of “very experienced team members,” both from the firm and also with “external expertise,” after the Swedish pure play developer received a US Food and Drug Administration complete response letter denying approval for its proposed Xlucane (ranibizumab) biosimilar to Lucentis.

The setback comes nine months after Xbrane refiled its Xlucane biologics license application to the agency – that following a May 2022 withdrawal of the application after the FDA told the firm that

More from Biosimilars

More from Products

Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

 
• By Dean Rudge

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.

Teva’s Uzedy Continues Surge As Olanzapine LAI Filing Nudges Closer

 
• By Dean Rudge

Teva underlined that it was “very pleased with this franchise we’re building and what we’ll bring to the care of patients with schizophrenia,” as it looks ahead to filing its olanzapine new drug application in the second half of 2025.

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By Dave Wallace

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.