Celltrion receives CHMP positive opinion for trastuzumab biosimilar, Herzuma® (CT-P6)
The CHMP recommended Herzuma® (CT-P6) for approval in early breast cancer, metastatic breast cancer and metastatic gastric cancer
SATURDAY 15 DECEMBER 07:00 CET, INCHEON, SOUTH KOREA - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Herzuma® (trastuzumab biosimilar, CT-P6) be granted marketing authorisation in the European Union (EU) 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.[1] The CHMP’s opinion will now be sent to the European Commission (EC) for final review.
Herzuma® is a biosimilar to Herceptin®, reference trastuzumab, a breast cancer and gastric cancer biologic treatment developed by Genentech and marketed by Roche. Data show that Herzuma® has comparable efficacy and safety to reference trastuzumab®.[2],[3]
If approved, Herzuma® will be the second oncology biosimilar launched in Europe by Celltrion Healthcare following the launch of Truxima® (biosimilar rituximab) in 2017, which was the first biosimilar monoclonal antibody approved by the European Commission in an oncology indication.
Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “We are pleased to receive this positive opinion from the CHMP and look forward to the decision from the European Commission. We are preparing with our marketing partners to make this cost-effective alternative treatment available to patients and health systems across Europe”.
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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 epithelial 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.
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/
References
[1] Summary of CHMP opinion. Available here http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002575/WC500240426.pdf
[2] 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. 2017. Poster #152PD.
[3] 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 December 2017.