Regulations for biosimilar approval in Colombia

Category: Regulatory
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Abstract:
Columbia is in the process of implementing legislation to allow for the approval of biosimilar products so that they can enter the Columbian market. Three pathways for the submission of biosimilar products have been developed: the full dossier approach, comparability approach, and abbreviated comparability approach. These were outlined at the INVIMA Second Colombian Scientific Meeting on Quality Assessment of Biosimilars/Similar Biotherapeutic Products.

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