Nordic Life Science 1
TOP STORIES BUSINESS ACQU I SITIONS // AGREEMENTS
// COLLABORATIONS BUSINESS 3 x Disappointing FDA Updates Martin Åmark, CEO, Xbrane Biopharma 1 XBRANE BIOPHARMA The FDA has issued a Complete Response Letter (CRL) to the company’s Biologics License Application (BLA) for its ranibizumab biosimilar candidate for treatment of retinal disorders. The CRL refers to observations following a re-inspection of one of Xbrane’s contract manufacturers. “We are very disappointed about the FDA’s decision. We believe US patients and payors would significantly benefit from a more costefficient alternative to existing approved treatments against retinal disorders and we are committed to working swiftly towards a re-submission of the BLA,” stated Martin Åmark, CEO, Xbrane Biopharma. SWEDEN Karolinska and Akademiska strengthen collaboration on ATMP Karolinska ATMP Center and ATMP Center Uppsala have signed a letter of intent to deepen cooperation in the rapidly growing medical field of advanced therapies (ATMP), which includes medicines based on cells and genes. 2 XSPRAY PHARMA The FDA has issued a CRL regarding Xspray Pharma’s New Drug Application (NDA) for Dasynoc, referring to GMP observations at a contract manufacturer. No observations were specifically directed at the production line used for Dasynoc, but the FDA is pausing approvals of new products at the facility while corrective actions are being implemented. “It is unfortunate that manufacturingrelated issues beyond our control are delaying our launch,” stated Per Andersson, CEO, Xspray Pharma. Per Andersson, CEO, Xspray Pharma THE TWO CENTERS have decided to deepen their collaboration on the development and production of advanced therap drugs, including their own production of CAR-T treatments, as well as the implementation of clinical trials and treatments. The collaboration also includes joint training efforts and the exchange of knowledge and experience. The parties are also focused on strengthening international partnerships and collaborating with micro, small and medium-sized enterprises (SMEs) to promote innovation and growth in the ATMP area. The new letter of intent builds 3 Róbert Wessman, CEO, Alvotech ALVOTECH The FDA has issued a CRL for Alvotech’s BLA for AVT05 in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi. The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility (concluded in July 2025), must be satisfactorily resolved before this BLA for AVT05 can be approved. “While we are disappointed in receiving the CRL, we expect to resolve any outstanding issues and will continue to work with the FDA to bring this first-to-market biosimilar to patients in the US,” said Róbert Wessman, CEO, Alvotech. NLS The initiative was launched at a kick-off event in Uppsala on October 24, attended by Helena Proos (S), Chair of the Regional Board in Uppsala, and Aida Hadžialić (S), Financial Region Councilor in Stockholm. 12 | NORDICLIFESCIENCE.ORG on the previous agreement to strengthen the joint life science cluster in the Stockholm-Uppsala region. The long-term goal is to position the region as one of the world’s leading life science regions. NLS PHOTO ANITA SZAVA