Mundipharma has announced that Herzuma, biosimilar trastuzumab, is now available in Europe, with the product now launched in both the UK and Germany and further launches across European countries anticipated in the coming months.
The Mundipharma network has exclusive distribution rights to Herzuma
in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands.
Richard Trollope, Head of Oncology and Biosimilars at Mundipharma International Limited, said: “Building on our partnership with Celltrion Healthcare, we are pleased to announce that biosimilar trastuzumab is now available in Europe with national launches commencing in both the UK and Germany.
The availability of biosimilar trastuzumab will provide an alternative treatment option to the thousands of eligible patients across Europe with early breast cancer, metastatic breast cancer or metastatic gastric cancer.”
Herzuma, a biosimilar of i.v. Herceptin®, was granted marketing authorisation on 9 February 2018 for the treatment of patients with early breast cancer, metastatic breast cancer or metastatic gastric cancer whose tumours have either HER2 overexpression or HER2 gene amplification, following positive opinion and recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2017.
Biosimilar trastuzumab has the potential to make significant cost savings for healthcare organisations, releasing healthcare resource for other innovative medicines.
Alberto Martinez, President and CEO, Mundipharma International Limited, said: “Mundipharma has a proven track record of launching biosimilars successfully in Europe, which is illustrated by CelltrionHealthcare entrusting us once again with the launch of biosimilar trastuzumab across key European markets. As biosimilar trastuzumab continuesto launch in additional countries, we look forward to assisting healthcare economies across Europe wanting to deliver better value to patients.”
Herzuma is the third biosimilar to be marketed and distributed by the Mundipharma network in Europe, having launched Remsima® (infliximab), the first biosimilar monoclonal antibody, in 2015, and Truxima® (rituximab), the first biosimilar monoclonal antibody for the treatment of cancer, in 2017.
