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Amgen submits trastuzumab biosimilar to EMA Posted 24/03/2017

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).

The news that the company had submitted an application to the European Medicines Agency (EMA) came during a presentation made by Amgen’s Executive Vice President and Chief Financial Officer David Meline at the Cowen and Company 37th Annual Health Care Conference, which was held in Boston, USA on 6−8 March 2017.

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 over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Amgen/Allergan’s product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had sales of CHF 6.8 billion (US$6.7 billion) in 2016. The patents on Herceptin expire in the US in June 2019 and expired in Europe in July 2014 [1].

The company announced positive results from their phase III trial, which evaluated the efficacy and safety of ABP 980 compared to Herceptin in patients with HER2+ early breast cancer, in July 2016 [2].

Mr Meline also indicated during his presentation that Amgen is looking to file for approval in the US, however, the timing for any potential filing was not revealed.

Rival biosimilars makers Mylan and Biocon submitted an application for their trastuzumab biosimilar to EMA in August 2016 [3] and to the US Food and Drug Administration in November 2016 [4]. Meanwhile, South Korean biosimilars makers Celltrion and Samsung Bioepis submitted their applications for trastuzumab biosimilars to EMA in November 2016 and August 2016, respectively [5, 6].

Related articles
Biosimilars applications under review by EMA – December 2016

Biosimilars of trastuzumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 24]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. 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 2017 Mar 24]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Amgen-s-trastuzumab-biosimilar
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 2017 Mar 24]. 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 trastuzumab biosimilar to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 24]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-FDA
5. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits trastuzumab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 24]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-trastuzumab-biosimilar-application-to-EMA
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 24]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-trastuzumab-biosimilar

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Source: Big Molecule Watch, Cowen Group

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