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Mylan presents comparability data for trastuzumab biosimilar Posted 01/07/2016

Generics giant Mylan Pharmaceuticals (Mylan) presented robust data from its biosimilar trastuzumab programme at the American Society of Clinical Oncology (ASCO) Annual Meeting ASCO 2016 held in Chicago, USA on 3–7 June 2016.

Mylan and partner Biocon presented data from the companies’ phase III HERiTAge study for their biosimilar trastuzumab candidate, Myl 1401O. According to Mylan, the results of the double-blind, randomized, parallel group, study confirmed the efficacy, safety and immunogenicity of Myl-1401O compared to Roche’s Herceptin (trastuzumab) both given in combination with paclitaxel as first-line therapy every three weeks in patients with HER2+ metastatic breast cancer.

Worldwide, nearly two million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. HER2+ metastatic breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth. Approximately 20% to 30% of primary breast cancers are HER2+.

The HERiTAge trial reportedly met the predefined primary endpoint of overall response rate (ORR; according to Response Evaluation Criteria in Solid Tumour [RECIST] 1.1 criteria) at Week 24. The response rates at 24 weeks were 69.6% with Myl-1401O versus 64% with Herceptin. The ratio of overall response and difference in overall response also fell within a narrow, predefined equivalence margin [ORR was 1.09; 90% CI (0.974–1.211) and 95% CI (0.954–1.237)], which lead author Dr Hope S Rugo says suggests ‘equal efficacy of both products’.

Secondary endpoints included progression free survival (PFS), overall survival and safety. The rates of serious adverse events (primarily neutropenia related) were 38% with Myl-1401O and 36% with Herceptin and ‘there was no difference in cardiac safety’, according to Dr Rugo.

The ongoing trial is being carried out in 500 patients in Brazil, Chile, Georgia, Hungary, India, Latvia, Peru, Romania, Russia, Serbia, Slovakia, South Africa, Thailand, Turkey and Ukraine and is expected to be completed in December 2018.

Biocon and Mylan have already had a trastuzumab ‘similar biologic’ (CanMab) approved in India back in 2013 [1]. While Celltrion’s trastuzumab biosimilar Herzuma (CT-P6) is being marketed in South Korea following approval in January 2014 [2].

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

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1. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Ju1 1]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea

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Source: ASCO, ClinicalTrials.gov, Mylan

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