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Drug Industry Daily
June 4, 2012 | Vol. 11 No. 109
Updated EMA Biosimilars Guidance Seeks Extensive Side-by-Side Quality Comparison
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 updated guidelines.
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