A biosimilar is a biologic drug that is similar to an approved biologic drug (reference product), but with minor variations in its inactive components, giving it no clinically meaningful difference.
Fresenius Kabi understands the importance of biosimilars and what they can bring to our patients’ lives. This understanding is the driving force behind our knowledge, expertise and commitment to the science of biosimilars.
We are committed to the effective and safe treatment of our patients, taking painstaking detail and using astute analysis to ensure that these goals are met. For our biosimilar products to be approved, they are subjected to the following:
- 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, whether in ideal conditions or in the case