mAbxience | Business Growth Story

Business
Growth Story

  • Founded by Dr. Hugo Sigman
  • PharmaADN & Munro: mAbxience Argentina R&D & biomanufacturing.

2010-2012

  • Genhelix: mAbxience Spain R&D center
  • First launch of MB01 rituximab (Novex®, Argentina)

2014-2015

  • First launch of MB02 bevacizumab (Bevax®, Argentina)
  • “Biosimilar Initiative of the Year” Award 2016 by GGBA.”
  • EMA GMP certification granted to mAbxience Spain.

2016-2017

  • Partnered worldwide with MB02 bevacizumab biosimilar.
  • “Business Development of the Year” Award 2018 by GGBA.

2018-2019

  • 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.

2020-2021

  • 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.

2022-Present

GMP: Good Manufacturing Practices

EMA: European Medicines Agency

FDA: US Food Drug Administration

GGBA: Global Generics & Biosimilar Awards