mAbxience | Our story: moving forward
Our story:
moving forward
- 2009
- Established in Europe
- Start of R&D activities
- 2010
- Acquisition and start of construction of pharmADN (mAbxience Buenos Aires plant)
- 2012
- mAbxience Buenos Aires plant: inauguration
- GMP certification granted for mAbxience Buenos Aires facility through successful ANMAT inspection
- First industrial batch
- First clinical trial recruitment (rituximab)
- 2013
- Clinical trial recruitment (bevacizumab)
- 2014
- Genhelix biopharmaceutical plant acquisition (León, Spain)
- Novex® (rituximab) launch in Argentina
- 2015
- mAbxience León plant: inauguration
- 2016
- Bevax® (bevacizumab) launch in Argentina
- Project with WHO and UCAB to develop Palivizumab biosimilar
- Biosimilar Initiative of the Year Award 2016 by Generics Bulletin
- 2017
- European GMP certification granted for mAbxience León facility, through successful AEMPS inspection
- Initiation of project for the construction of a new monoclonal antibodies manufacturing plant in Buenos Aires
- Expansion of global access of rituximab
- Scientific Advices with the EMA and the FDA
- Clinical trials of rituximab and bevacizumab completed
- 2018
- GMP certification to mAbxience León following the successful inspection by the Turkish Medicines And Medical Devices Agency
- Business Development of the Year Award 2018 by Generics Bulletin
ANMAT: National Administration of Drugs, Foods and Medical Devices.
WHO: World Health Organization
UCAB: Utrecht Centre for Affordable Biotherapeutics
GMP: Good Manufacturing Practices
AEMPS: Spanish Agency for Medicines and Medical Devices
EMA: European Medicines Agency
FDA: Food Drug Administration
