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Xbrane Receives FDA Concurrence on Streamlined Development Plan for Opdivo Biosimilar, Xdivane

  • Xbrane Biopharma received positive scientific advice from the FDA regarding its Opdivo biosimilar candidate, Xdivane, aligning with EMA feedback.
  • The FDA supports Xbrane's streamlined clinical development plan, which includes a single clinical trial, significantly reducing the development budget by at least 60%.
  • Xbrane is focusing on a global market strategy for Xdivane, targeting US launch by December 2028, and is actively seeking commercialization partners.
  • Opdivo, an immune-oncology drug (PD-1 inhibitor), had global sales of approximately $8 billion in 2023, projected to reach $14 billion by 2028.
Xbrane Biopharma AB has announced that the U.S. Food and Drug Administration (FDA) has concurred with the European Medicines Agency's (EMA) feedback on its proposed streamlined clinical development plan for Xdivane™, a biosimilar candidate for Opdivo® (nivolumab). This agreement paves the way for a significantly more efficient and cost-effective development pathway. The FDA's feedback supports Xbrane's Biologics License Application (BLA) strategy, potentially enabling a launch upon Loss of Exclusivity in the US in December 2028.

Streamlined Clinical Development

Xbrane's development plan for Xdivane™ now involves a single clinical trial, a departure from the traditional approach of separate Phase 1 and Phase 3 trials. This streamlined approach is projected to reduce the clinical development budget by at least 60%, from approximately €120 million to €50 million or less. The design also limits the number of patients, making it feasible to finalize the trial in time to support submission of a BLA latest Q4 2027.

Market Opportunity and Commercialization Strategy

Opdivo®, a PD-1 inhibitor, is a key drug in immune-oncology, used to treat various cancers. In 2023, Opdivo® generated approximately $8 billion in global sales, with projections estimating growth to $14 billion by 2028. Xbrane is positioning Xdivane™ for a global market, aiming for approval and launch in time for the U.S. loss of exclusivity in December 2028. The company, supported by a life science advisor, is actively engaged in an out-licensing process with multiple potential partners, with the goal of finalizing an agreement in the coming months.

Xbrane's Biosimilar Platform

Xbrane Biopharma AB develops biological drugs using a patented platform technology designed to lower production costs compared to competing systems. Xbrane's portfolio includes biosimilar candidates targeting an estimated €26 billion in annual peak sales of the respective reference products. Ximluci®, Xbrane’s lead candidate, has already received market authorization in Europe and was launched in 2023.
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Reference News

[1]
Xbrane provides update from Scientific Advice with US FDA on Xdivane™ (Opdivo ...
placera.se · Sep 27, 2024

Xbrane Biopharma received FDA's scientific advice on its Opdivo® biosimilar candidate Xdivane™, agreeing with EMA's prev...

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