Celltrion's Trastuzumab Biosimilar Launches in Europe

Trastuzumab competition in the European market is heating up as Mundipharma announced yesterday that it has officially launched Celltrion’s trastuzumab biosimilar, Herzuma. The product is now available in both the United Kingdom and Germany, with further launches across Europe anticipated in the coming months. Celltrion has granted Mundipharma exclusive distribution rights to the biosimilar in the United Kingdom, Germany, Italy, Belgium, Luxembourg, and the Netherlands.

The biosimilar, referencing Roche’s Herceptin, was granted marketing authorization on February 9, 2018, following a positive opinion and recommendation for approval by the European Medicine’s Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2017. Herzuma has been approved 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.

“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 [United Kingdom] and Germany. The availability of a 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,” said Richard Trollope, head of oncology and biosimilars at Mundipharma, in a statement.

This launch comes on the heels of the commercial availability of Ontruzant, developed by Samsung Bioepis, which became the first trastuzumab biosimilar introduced in Europe when it entered the UK market on March 8, 2018. The biosimilars will now be competing for market share with brand-name Herceptin, which is among the top-selling drugs in the global marketplace, having earned $6.75 billion in sales in 2016.

In addition to launching its drug in the United Kingdom, Samsung Bioepis also filed for US regulatory review of its trastuzumab biosimilar. However, the potential to launch a trastuzumab biosimilar in the US market has proven difficult. Pfizer received a Complete Response Letter (CRL) on April 23, 2018 from the FDA requesting more information about their trastuzumab biosimilar; adding to Celltrion receiving its own CRL on April 5, 2018 due to the FDA citing concerns about manufacturing practices.

To date, the FDA has only approved 1 trastuzumab biosimilar, Ogivri, developed by Mylan and Biocon, though no launch date has yet been set.