Biosimilars

Welcome to the Biosimilars section of the Biosimilars in Oncology Knowledge Centre. This section contains information on the development and manufacture of biosimilars, how they are regulated, what use they have in clinical practice and more.

What is a Biosimilar?

What is a Biosimilar?

Discover what the similarities are between biological medicines and biosimilars, such as amino acid sequence, pharmacodynamics, pharmacokinetics and immunogenicity.

Extrapolation of Indication

Extrapolation of Indication

The extrapolation of indication refers to the granting of regulatory approval without conducting a clinical trial, which can be used with biosimilars.

Pharmacovigilance

Pharmacovigilance

Discover the importance of an effective pharmacovigilance system to effectively monitor the safety of the biosimilars.

The Potential Benefits of Biosimilars

The Potential Benefits of Biosimilars

Learn about the numerous benefits of using biosimilar medications, such as reduced cost and the driving of competition.