Mundipharma expands its European footprint with Herceptin biosimilar

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Mundipharma partners with Prestige to commercialize and supply a biosimilar to Roche’s Herceptin, for patients with breast, gastric and gastroesophageal cancer.

The Cambridge, UK-based company announced a partnership with Prestige Biopharma, a Singaporian biosimilar developer, to exclusively distribute, market and sell Tuznue, a trastuzumab biosimilar treatment.

Mundipharma Europe will distribute the product in selected European countries including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.

Tuznue is a biosimilar to Roche’s Herceptin, which is used to treat patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer, HER2-overexpressing metastatic gastric cancer and gastroesophageal junction adenocarcinoma.

The European Medicines Agency (EMA) recently accepted a marketing authorisation application (MAA) for Tuznue, based on positive top-line results from global clinical trials.

This agreement sees the number of Mundipharma’s biosimilar partnerships for distribution in Europe rise to three, further building its footprint in the market.

Previously, Mundipharma partnered with Celltrion to commercialise Herzuma, another trastuzumab biosimilar, in seven European countries and has also launched Celltiron’s versions of J&J’s Remicade (infliximab), Remsima, and Roche’s Mabthera (rituximab), Truxima, within Europe.

“Using our collective expertise, Prestige in development, and us in commercialisation we can continue to reduce the financial burden for even more healthcare systems,” said Alberto Martinez, CEO of Mundipharma Europe.

Lisa Park, Prestige’s CEO commented that the partnership “will further increase the global availability of our trastuzumab biosimilar so that more patients can benefit from its quality and accessibility.”

“We envisage the partnership with Mundipharma to grow strong to encompass more programs in the future,” she added.

The product is expected to reach the market by the end of 2020.