The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 March 2018 that it had recommended granting marketing authorization for the trastuzumab biosimilar Kanjinti.
Kanjinti (ABP 980) has been co-developed by Biotech giant Amgen and partner Allergan. The pair submitted their application for the trastuzumab biosimilar to EMA in March 2017 [1].
The product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 7.0 billion (US$7.5 billion) in 2017. The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [2].
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.
The CHMP has recommended that Kanjinti be approved for the same three types of cancer as Herceptin is approved for in the European Union (EU), including HER2-positive (HER2+) metastatic breast cancer, HER2+ early breast cancer and HER2+ metastatic adenocarcinoma of the stomach or gastroesophageal junction. The positive opinion will now be referred to the European Commission (EC), which grants marketing authorizations for medicines in the EU.
The marketing authorization application for ABP 980 was supported by analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The phase III comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2+ early breast cancer [3].
Amgen already has three biosimilars approved in the EU: Amgevita (adalimumab), Mvasi (bevacizumab) and Solymbic (adalimumab) [3]. The company also gained US approval for Amjevita (adalimumab-atto) in September 2016 and for Mvasi (bevacizumab-awwb) in September 2017 [4]. It has also submitted applications for approval of its proposed trastuzumab (ABP 980) and adalimumab (ABP 501) biosimilars to the US Food and Drug Administration [5, 6].
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Amgen submits trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Biosimilars/News/Amgen-submits-trastuzumab-biosimilar-to-EMA
2. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Amgen’s trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6] Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Amgen-s-trastuzumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Two trastuzumab biosimilars submitted to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Biosimilars/News/Two-trastuzumab-biosimilars-submitted-to-FDA
6. GaBI Online - Generics and Biosimilars Initiative. Amgen submits biosimilar adalimumab application to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Biosimilars/News/Amgen-submits-biosimilar-adalimumab-application-to-FDA
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