Herzuma® (CT-P6) granted EU marketing authorisation to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer
WEDNESDAY 14 FEBRUARY, INCHEON, SOUTH KOREA – Celltrion Healthcare today announced that the European Commission (EC) has approved Herzuma® (trastuzumab biosimilar, CT-P6) for all indications of reference trastuzumab in the European Union (EU). The approval of Herzuma® marks the third Celltrion Healthcare product approved in the EU and builds on the company’s expanding biosimilar portfolio.
Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “We are delighted to receive marketing authorisation of Herzuma® as we are now able to offer two biosimilar monoclonal antibodies in oncology following the launch of Truxima® (biosimilar rituximab) in 2017. This means with the help of our partners across Europe, we can persevere with our aim of ensuring these important biologic treatments are made available to the millions of patients who can benefit from them.”
The EC decision allows the marketing of Herzuma® in all 28 EU member states and the European Economic Area for the treatment of people with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumours have either HER2 overexpression or HER2 gene amplification.
The approval follows a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December and is based on the totality of evidence submitted. The supporting data showed that Herzuma® and reference trastuzumab were highly similar in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK). ,
Celltrion Healthcare also held their annual Partner Summit in Venice earlier this month where 26 of their European partners gathered to discuss local market launches for Herzuma® following its successful approval. Richard Trollope, Head of Biosimilars, Mundipharma speaking at the event, said, “There is an increasing number of European national healthcare systems that are challenged by the high cost burden of oncology treatments. Subsequently, the approval of Herzuma® will be greatly welcomed, as it provides a high-quality treatment alternative for patients, while offering significant potential savings and headroom for other oncology treatments.”
Notes to editors:
About CT-P6 (biosimilar trastuzumab)
CT-P6 is a monoclonal antibody (mAb) – a protein designed to recognise and bind to a specific structure or antigen in the body. CT-P6 has been designed to bind with high affinity and specificity to the extracellular domain of human epidermal growth factor receptor (HER2).
HER2 is found to be overexpressed and/or amplified in about 15-20% of patients with the diseases for which reference trastuzumab is indicated. By binding to HER2 receptor binding domains on the tumor cells, trastuzumab inhibits proliferation of HER2 overexpressing tumour cells.
Celltrion has carried out extensive studies between CT-P6 and reference trastuzumab to establish that they are highly similar in physicochemical and biological attributes. Studies have also demonstrated comparability in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity and safety.
Herzuma® is a biosimilar to Herceptin®, a biologic drug developed by Genentech and marketed by Roche. Herceptin® is a blockbuster drug which had worldwide sales of CHF 6.8 billion (US$6.8billion) in 2016, of which CHF 2.1 billion (US$2.1 billion) was in European sales. 
CT-P6 is also currently under review by the FDA but not yet an approved product in the U.S.
About Celltrion Healthcare
Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/
 Esteva et al. Double-blind randomized phase III study to compare the efficacy and safety of trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer (EBC). European Society for Medical Oncology. 2018. Poster #152PD.
 Stebbing et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled phase 3 equivalence trial. The Lancet Oncology. (18:7) p917–928. July 2017. Available at http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30434-5/fulltext. [Last accessed February 2018.]
 Herceptin® is a registered trademark of Genentech Inc.
 Roche Financial Report 2016. Available at: https://static.roche.com/annual-report-2016/_downloads/roche_full_financial_report16.pdf [Last accessed February 2018.]