Biosimilar Herzuma approved in EU

The European Commission (EC) has approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification.
The positive decision for South Korean firm Celltrion (Kosdaq: 068270) follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 14, 2017. It follows the EC approval of Samsung Bioepis’ trastuzumab biosimilar, Ontruzant, in November last year.
Other biosimilars of Roche’s blockbuster breast and gastric cancer drug Herceptin include the partnership of India’s Biocon (BSE: 532523) and Netherlands-headquartered Mylan (Nasdaq: MYL), with the latter duo one of the leaders in the race for approval in the USA, where the last composition of matter patent for the original will expire in 2019.Herceptin sales in full-year 2017 grew 3% to 7.01 billion Swiss francs ($7.5 billion).
“The development of biosimilar is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal against a variety of diseases and to increase patients’ accessibility to innovative drugs at a more affordable price,” said Woosung Kee, chief executive of Celltrion, adding: “We have already seen many benefits of biosimilars in Europe from our experience with Remsima and Truxima. Our experience has shown that biosimilars not only reduce individual patient’s out-of-pocket medical expenses but also contribute to lowering financial burden on insurance payers and national health agencies.”
The European Commission’s approval of Herzuma marks an important milestone for Celltrion, providing more treatment options for patients. Herzuma is the third biosimilar from Celltrion’s portfolio approved by the EC.
This decision by the European Commission means that Herzuma is now approved for marketing in the 28 member states of the European Union (EU), in addition to Norway, Liechtenstein and Iceland.


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