(Treffer aus pharmind, Nr. 05, Seite 668 (2015))
Biosimilars / Hurdles and Challenges from the Development to a Successful Launch · Mikhail M · Lambsheim
The European Union (EU) is currently clearly the largest biosimilar market with the most advanced regulatory pathway. Since November 2005 several biosimilars have already been approved in the EU. The US-FDA is creating own biosimilars Guidelines and requests extra clinical data to grant inter-changeability status. Is it worthwhile to develop a biosimilar drug? A case study figuring the example of developing a biosimilar Granulocyte-Colony Stimulating Factor (G-CSF) addresses this question showing the complexity of the comparability exercise: a marriage without divorce where the biosimilar drug should match the reference product in every step. The post-approval risk management plan and traceability ...