STADA and Xbrane announced that their commercialization agreement with Bausch + Lonb has been terminated, and that they are considering options for their co-developed ranibizumab biosimilar to Genentech’s Lucentis® (Ximluci®) in North America.
Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.
After receiving EU approval in November 2022, STADA and Xbrane intend to commercialise the product in the US. On 22 June 2023, Xbrane announced the FDA has accepted a supplemental Biologics License Application (sBLA) for (Ximluci®).