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EMA Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins (2012)
EMA Guideline On Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substance: Quality Issues (Revision 1) (2012)
Retrieved From
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf