Can I read ICH Guidelines for Biosimilar Approval on EtoBox?
ICH Guidelines for Biosimilar Approval by nh0101 F is a document available to read on EtoBox.
What is ICH Guidelines for Biosimilar Approval about?
The document proposes new International Council for Harmonization (ICH) guidelines for the approval of biosimilars to enhance global regulatory consistency and reduce development costs. It argues that current animal and clinical efficacy testing is often unnecessary and suggests that modern analytical technologies can better establish biosimilarity. The proposed guidelines aim to improve access to biosimilars, particularly in emerging countries, by streamlining the approval process and eliminating redundant
- Author
- nh0101 F
- Language
- EN