Fresenius Kabi biosimilars

Fresenius Kabi has become a well-established provider of enhanced patient care and is now bringing this expertise to biosimilars in order to unlock lifesaving biosimilar treatments for more patients.

 

We are committed to the effective and safe treatment of our patients, taking painstaking detail and using state-of-the-art analysis to ensure that these goals are met. For our biosimilar products to be approved, they are subjected to the following:1

 

  • Comparative testing to the approved biologic drug
  • Analytical studies proving that our biosimilar product is similar in molecular characteristics to the approved product
  • Clinical studies clearly illustrating efficacy, safety, pharmacokinetics and pharmacodynamics comparable to the approved drug, in healthy volunteers and/or patient studies

Biosimilars are highly similar to reference biologics
 


What are biosimilars? Learn here

Reference
1. European Medicines Agency (EMA). Biosimilars in the EU: Information guide for healthcare professionals. 2017. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf (Accessed February 2019).

FK/BIO/022/18 | February 2019