Home > Newsletters > International Pharmaceutical Regulatory Monitor > Updated EMA Biosimilar Guidance Seeks Side-by-Side Quality Analysis
International Pharmaceutical Regulatory Monitor
June 2012 | Vol. 40 No. 6
Updated EMA Biosimilar Guidance Seeks Side-by-Side Quality Analysis
Biosimilars’ molecular characteristics should mirror those of the reference biologic as closely as possible, while the performance and consistency of the biosimilars’ manufacturing process should stand on its own, the European Medicines Agency (EMA) says in an updated guideline. Includes the full text of EMA Guideline on Biosimilar Quality Comparisons.
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