Biologics face unique regulatory challenges compared to traditional small molecule drugs. Due to their complex nature, the approval pathway for biologics involves extensive evaluation and scrutiny. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have developed specific guidelines and frameworks to assess the safety and efficacy of biologics.
One critical aspect in the regulatory evaluation of Biologics is the demonstration of similarity or comparability. This is particularly relevant for biosimilars, which are highly similar but not identical to reference biologics. Extensive analytical, functional, and clinical studies are conducted to establish the similarity of the biosimilar to the reference product, ensuring no significant differences in safety and efficacy.
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