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Advances for Samsung Bioepis’ eculizumab and trastuzumab biosimilars

Biosimilars/Research | Posted 26/11/2021 0 Post your comment

Samsung Bioepis has announced the completion of its global phase III clinical trials of a biosimilar of Soliris (eculizumab), for treating certain rare blood diseases. In addition, it also presented its results from a five-year follow-up study that showed its biosimilar Ontruzant (trastuzumab) has comparable cardiac safety profiles and long-term efficacy as the originator, Herceptin.

Samsung Bioepis’ phase III trial of its eculizumab biosimilar began in 2019 and was completed in October 2021. The trial was carried out in eight countries, including South Korea. Its eculizumab product is a biosimilar of the highly priced, Soliris, developed by US pharmaceutical company, Alexion. Eculizumab is used to treat rare blood diseases paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Samsung hopes that this product can soon be added to its portfolio of approved biosimilars and helps improve patients access to expensive biological medicines.

At the European Society for Medical Oncology (ESMO) Virtual Congress 2021, in September 2021, Samsung Bioepis presented the longest monitoring data of patients treated with a trastuzumab biosimilar versus the originator, Herceptin, for human epidermal growth factor receptor 2 positive (HER2+) early or locally advanced breast cancer. They were able to show comparable cardiac safety profile and long-term efficacy between biosimilar Ontruzant and the originator, Herceptin. Ontruzant has been approved in several jurisdictions, including Australia, Brazil, Europe, South Korea and the US [1].

Biosimilar advances for Samsung Bioepis

Biosimilars approved in South Korea

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View last week’s headline article: Regulación del registro de medicamentos biológicos en América Latina Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de la semana pasada: Regulación del registro de medicamentos biológicos en América Latina Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 26). Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab

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