Celltrion Grants European Trastuzumab Biosimilar Marketing Rights to Mundipharma

South Korean-based drug manufacturer, Celltrion, has granted exclusive distribution rights of its trastuzumab biosimilar, Herzuma, to the Mundipharma global network of independent associated companies. The rights apply to 7 European nations.

“We are pleased to be partnering once again with Mundipharma on the commercialization of our trastuzumab biosimilar,” said Man Hoon Kim, president and chief executive of Celltrion in a statement. “They have a proven track record of launching biosimilars in Europe, working effectively across multiple healthcare systems and demonstrating local in-market expertise. This alliance enables us to continue to pursue our commitment to delivering effective and affordable medicines which benefit healthcare systems, healthcare professionals and patients.”

Richard Trollope, commercial head of oncology and biosimilars at Mundipharma, added, “Celltrion’s decision to entrust us with a third biosimilar from their portfolio is testament to the insight and experience we have developed from successfully launching [2] previous monoclonal antibody biosimilars. With infliximab [Remsima], we achieved market-leading status in the majority of our markets, and we are already seeing strong market uptake with our newest biosimilar medicine, rituximab [Truxima], across those markets where we have distribution rights.”

The trastuzumab biosimilar was granted marketing authorization on February 9 of this year after receiving a positive opinion and recommendation for approval by the European Medicines Agnecy’s and the Committee for Medicinal Products for Human Use in December 2017. The biosimilar is approved for treatment of HER2-positive early breast cancer in the neo-adjuvant and adjuvant setting, metastatic breast cancer, and metastatic gastric cancer in adults.

Herzuma will not be the only trastuzumab biosimilar on the market in Europe. Samsung Bioepis, another Republic of Korea drug maker, has also received marketing authorization for its own trastuzumab biosimilar. The biosimilar is being commercialized by Merck and will be marketed in Europe as Ontruzant. Both products will compete with the reference trastuzumab, Herceptin, which generated global sales of $7.4 billion for developer Roche in 2017.