Privatsphäre-Einstellungen

Pharmakovigilanz bei Biosimilars

Anforderungen an die gesetzlich festgelegten Vorgaben zur Überwachung der Sicherheit und der Nutzen-Risiko-Bewertung

Dr. Elizabeth Storz¹ und Dr. Sabine Sydow²

vfa – Verband der forschenden Pharma-Unternehmen¹, Berlin, und vfa bio – Biotechnologie im vfa², Berlin

According to EU pharmaceutical legislation biosimilar products (biosimilars) are defined as being biological medicinal products (biologicals) which are similar but not identical to an originator product. The reason being that the raw materials and manufacturing processes are different and, as a consequence, the final product will vary from the reference medicinal product. Due to the very complex structure of biopharmaceuticals the regulatory requirements for biosimilars exceed those for generic products. Even if the efficacy is shown to be comparable, biosimilars may exhibit a different safety profile compared to the originator product. Therefore it is even more important that continuous monitoring of the benefit-risk-profile is performed after authorization. Due to the very complex nature of biosimilars the question can be raised: is the legal framework for monitoring of their safety and benefit-risk-assessment sufficient? This question can be answered with “yes, but . . .” which will be shown in the following article.