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International discussion on complex drugs

On October 7, 25 international academic and industrial experts and regulators discussed the bioequivalance of Complex Drugs in Leiden. 

Conventional small molecule drugs are considered to be therapeutically equivalent to a reference drug once pharmaceutical equivalence (ie, identical active substances) and bioequivalence (ie, comparable pharmacokinetics) have been established. This means that no formal clinical efficacy and safety studies are needed. Since the introduction of a regulatory pathway for biosimilars in the EU, six different protein products were introduced and two products were rejected or withdrawn. However, a scientific and regulatory rationale for comparative pharmacokinetics for biologics is lacking. Therefore, a reevaluation of the approach to show bioequivalence is needed. TI Pharma acted as a neutral platform for discussion between the different stakeholders. The outcome of the discussions will be published in a whitepaper.

This workshop was co-organized with Vifor Pharma, Teva Pharmaceutical Industries, and Sanofi-Aventis.