🚀 How is the EMA’s new biosimilar clinical approach changing the landscape of drug approvals in Europe?
With a focus on tailored clinical assessments, the EMA is streamlining the pathway for biosimilars by allowing analytical data to take precedence over large-scale comparative efficacy studies. This shift promises to enhance patient access to life-saving therapies while maintaining rigorous safety standards.
Dive deeper into the implications of this innovative regulatory approach and find out how it can impact health economics and market access.
👉 Read more in the full article!
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