mAbxience | Our story: moving forward
mAbxience was founded in 2009 as the biotech unit of the Spanish multinational Insud Pharma. A year later, the construction of mAbxience Buenos Aires facilities began.
In 2012, the Buenos Aires manufacturing plant was inaugurated and Argentinian GMP (Good Manufacturing Practices) certificate was obtained through satisfactory inspection of ANMAT. The first industrial batch was completed, while recruitment for the first clinical trial (rituximab) was initiated. Recruitment for the second clinical trial started in 2013 (bevacizumab).
Over the next few years, mAbxience took important steps towards consolidating its business internationally. In 2014 it acquired 100% of the biopharmaceutical plant Genhelix, located in León (Spain) and launched its first biosimilar product in Argentina: Novex® (rituximab). In 2015 the mAbxience León facility was inaugurated.
In 2016, mAbxience was chosen by the World Health Organization (WHO) and the Utrecht Centre for Affordable Biotherapeutics (UCAB) to lead the project of development of palivizumab biosimilar. Moreover, its second biosimilar product, Bevax® (bevacizumab) was launched in Argentina.
To finish off the year, mAbxience received the Biosimilar Initiative of the Year Award 2016 awarded by the prestigious magazine Generics Bulletin within the framework of the Global Generics & Biosimilars Awards.
In 2017, mAbxience León facility obtained the GMP (Good Manufacturing Practices) certificate through satisfactory inspection by the Spanish Agency of Medicines and Medical Devices (AEMPS). In turn, the expansion of global access of rituximab was initiated, as well as Scientific Advices with the EMA (European Medicines Agency) and the FDA (Food and Drug Administration); both rituximab and bevacizumab clinical trials were completed. At the end of the year, a project for the construction of a new monoclonal antibodies manufacturing plant in Buenos Aires was initiated.