ARCS Conferences

Biosimilars – Why are there special regulatory requirements? (F13)

Synopsis

When an innovator registers a new chemical entity, full quality, preclinical (toxicology) and clinical data are submitted in support of the application. After expiry of any relevant patent, generic versions may be registered on the basis of quality and bioequivalence data. The bioequivalence study compares the plasma concentration / time profiles of the generic and innovator using statistical and clinical criteria. If they are deemed equivalent, new toxicology and clinical data are not required.
But that’s for a small molecule. Why are there different requirements for second entry biological medicines? The guidelines for these products still require pharmacokinetic data, but these are not sufficient for registration as is the case for small molecules. Regulatory requirements for biosimilars will be discussed and explained.

Learning objectives:

• Knowledge of regulatory requirements for second entry biological medicines
• Understanding why these requirements are different to those for second entry small molecules

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