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EMA Concept Paper: Revision of the Guideline on Similar Biological Medicinal Products
Biosimilar medicines have become an integral part of modern healthcare by expanding patient access to biological therapies while maintaining high standards of quality, safety, and efficacy. As scientific knowledge, analytical technologies, and regulatory frameworks continue to evolve, regulatory guidance must also adapt to reflect these advancements. The Concept Paper on Revision of the Guideline on Similar Biological Medicinal Products sets out the European Medicines Agency'
Sharan Murugan
3 hours ago3 min read
EMA Concept Paper: Guideline on Mechanistic Models in Model-Informed Drug Development (MIDD)
The European Medicines Agency (EMA) has released a concept paper proposing the development of a guideline for the assessment and...
Sharan Murugan
Feb 22, 20252 min read