Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 8 November 2016 that they had submitted the marketing application for their proposed trastuzumab biosimilar (Myl-1401O) to the US Food and Drug Administration (FDA).
Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.
Mylan/Biocon’s product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had sales of CHF 6.5 billion (US$6.6 billion) in 2015. The patents on Herceptin expire in the US in June 2019 and expired in Europe in July 2014 [3]. The companies believe that this may be the first submission of a proposed biosimilar trastuzumab in the US.
The submitted application includes a comprehensive package of analytical similarity, non-clinical and clinical data. The clinical data consists of two pharmacokinetic studies and the HERiTAge confirmatory efficacy and safety trial. Results from the phase III HERiTAge trial were presented during the American Society of Clinical Oncology (ASCO) annual conference ASCO 2016. 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 [1].
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and, although they have already had three biosimilar filings accepted for review by the European Medicines Agency (EMA) in 2016, this marks their first biosimilar submission in the US. Their proposed pegfilgrastim (MYL-1401H), trastuzumab (Myl-1401O) and insulin glargine biosimilars were accepted for review by EMA in July 2016 [2], August 2016 [3] and November 2016 [4], respectively.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan presents comparability data for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/Research/Mylan-presents-comparability-data-for-trastuzumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-EMA
4. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit insulin glargine biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-insulin-glargine-biosimilar-to-EMA
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