Mundipharma has picked up rights to Tuznue, a biosimilar of trastuzumab – Roche's Herceptin – from Singapore-based group Prestige Biopharma.
The agreement allows the Mundipharma network to distribute, market and sell Tuznue in selected European countries following marketing authorisation, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.
Herceptin is currently used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
The European Medicines Agency (EMA) is currently reviewing a marking application for Tuznue, which is based on positive top-line results from global clinical trials confirming that it is biosimilar to Herceptin in terms of clinical response and pharmacokinetics, in addition to having a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials, Mundipharma said.
“Using our collective expertise, Prestige in development, and us in commercialisation we can continue to reduce the financial burden for even more healthcare systems, while widening access to this important treatment for cancer patients,” noted Alberto Martinez, chief executive of Mundipharma Europe, commenting on the deal.