On 10 May 2024, Xbrane and Stada announced the exclusive licensing agreement with US biosimilars specialist Valorum Biologics for their ranibizumab biosimilar candidate.
Swedish biosimilar developer Xbrane and Germany’s STADA are responsible for completing the regulatory approval process for the ranibizumab candidate, and Xbrane is responsible for commercial manufacturing and supply. Valorum will be responsible for US commercialisation efforts for the product which is expected to be supplied as Lucamzi™.
On 21 April 2024, Xbrane announced that the FDA issued a Complete Letter Response regarding its ranibizumab BLA. Xbrane has not yet announced a resubmission date for the BLA.