Regulatory Hurdles and Scientific Rigor: Challenges in Approving Biosimilar Bevacizumab and Impact on Market Entry
Securing regulatory approval for biosimilar bevacizumab is a complex, multi-stage process that tests manufacturers’ scientific and operational capabilities. Unlike small-molecule generics, biosimilars are large, structurally complex proteins, requiring extensive analytical and preclinical studies to confirm similarity to the reference product. Regulatory bodies like the FDA, EMA, and...
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