Biosimilar Resources

Biologic medicine 

A medicine made using living cells or organisms. Biologic medicines are often used to treat complex diseases, including autoimmune diseases and cancer.

 

Biosimilar 

A biologic medicine that is highly similar to an already approved biologic medicine, with no clinically meaningful differences in quality, safety and efficacy. 

 

Biosimilarity 

The scientifically demonstrated similarity between a biosimilar and its reference medicine, based on extensive analytical, functional and clinical evidence.

 

Extrapolation 

A scientific and regulatory principle where a biosimilar may be approved for use in an indication of the reference medicine not directly studied in a comparative clinical trial, when justified by the totality of evidence.

 

Loss of exclusivity 

The point at which patent or other protections for a medicine expire, potentially allowing biosimilar to enter the market. A significant number of biologic medicines are expected to lose protection in the coming years.

 

No clinically meaningful differences 

A regulatory term meaning that the biosimilar has been shown to have no meaningful differences in expected clinical performance compared with the reference medicine.

 

Patient support program

A program that may provide information, tools or support to eligible patients, depending on the medicine, country and local regulations. Fresenius Kabi’s KabiCare support is available in selected markets.

 

Patient treatment days 

A measure used to estimate the number of days of therapy delivered to patients through access to medicines. Fresenius Kabi Biopharma is projected to deliver 1 billion patient treatment days by 2030.

 

Pharmacovigilance 

The ongoing monitoring of medicines after approval to identify and evaluate safety information. 

 

Reference medicine 

The already approved biologic medicine to which a biosimilar is compared during development and regulatory review.

 

Totality of evidence 

The full package of analytical, non-clinical and clinical data used by regulators to assess whether a proposed biosimilar is highly similar to its reference medicine.

 

Traceability 

The ability to track a medicine throughout the supply chain to help ensure quality, integrity and patient safety