Biosimilar monoclonal antibodies (mAbs) are essentially generic versions of their innovator counterparts. Antibodies with the same amino acid sequence are produced from different progenitor clones and manufacturing processes. Biosimilar mAbs may have a variety of differences owing to post-translational modifications, and this may affect quality. Regulatory authorities, including the FDA and EMA, have built regulatory frameworks over the last 20 years with specific guidelines.

The nature of antibodies means that the pharmacokinetics (PK) can be highly variable, even in the same disease. That is why PK studies are an indispensable component of the clinical program to establish biosimilarity. What is critical during development of biosimilar mAbs is also the demonstration of comparability and similarity to a reference product.

This session discusses the current pathway options for biosimilars from laboratory to clinical. We will cover evaluations as well as safety, pharmacology, and toxicity.