mAbxience | Business Growth Story
- Founded by Dr. Hugo Sigman
- PharmaADN & Munro: mAbxience Argentina R&D & biomanufacturing.
- Genhelix: mAbxience Spain R&D center
- First launch of MB01 rituximab (Novex®, Argentina)
- First launch of MB02 bevacizumab (Bevax®, Argentina)
- “Biosimilar Initiative of the Year” Award 2016 by GGBA.”
- EMA GMP certification granted to mAbxience Spain.
- Partnered worldwide with MB02 bevacizumab biosimilar.
- “Business Development of the Year” Award 2018 by GGBA.
- EMA approval for MB02 bevacizumab biosimilar.
- Manufacture of the AstraZeneca/Oxford Covid19 Vaccine.
- Garin: mAbxience Argentina new state-of-the-art biomanufacturing facility.
- MB02 bevacizumab Global Regulatory submission.
- Launch of CDMO services.
- 5 years of recognized safety standard OHSAS 18001:2007 Certification
- FDA & PMDA approval for MB02.
- EMA & FDA inspection at mAbxience Argentina and León respectively.
- Expansion of Spanish R&D center at Genhelix.
- Launch global CDMO platform strategy to all partners worldwide.
- Fresenius Kabi acquires a majority stake in mAbxience, joining Insud Pharma as shareholders.
GMP: Good Manufacturing Practices
EMA: European Medicines Agency
FDA: US Food Drug Administration
GGBA: Global Generics & Biosimilar Awards