Celltrion Healthcare?s anticancer therapeutics Herzuma? (trastuzumab) and Truxima? (rituximab) win Brazilian tender for two consecutive years
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About?Herzuma??(trastuzumab)
Herzuma??is a?humanised?monoclonal antibody that is designed to bind selectively to the extracellular domain of an antigen called human epidermal growth factor reception 2 (HER2).?Herzuma??is indicated for the treatment of adult patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer and was approved by the European Medicines Agency (EMA) in February 2018 and the US Food and Drug Administration (FDA) in December 2018. Similarity of?Herzuma??to the reference product, Herceptin??was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials.
About?Truxima??(rituximab)[1],[2]
Truxima??is a?mAb?that targets CD20, a transmembrane protein found on the surface of most B-cells. By binding specifically to CD20,?Truxima??depletes B-cells by three main mechanisms: induction of apoptosis, stimulation of CDC (complement-dependent cytotoxicity) and stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity).?Truxima??is approved in the EU and US for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic?leukaemia?(CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.?Truxima??is the first rituximab similar biotherapeutic product to be prequalified by the World Health Organization (May 2020).
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients? access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit:?https://www.celltrionhealthcare.com.
[1]?European Medicines Agency Summary of Product Characteristics (SmPC).?Truxima. Available at?https://www.ema.europa.eu/en/documents/product-information/truxima-epar-product-information_en.pdf?Last accessed July 2021
[2]?First rituximab similar biotherapeutic products prequalified. World Health Organization. Available at:?https://extranet.who.int/prequal/news/first-rituximab-biotherapeutic-products-prequalified?Last accessed July 2021