final manufacturing process / pharmaceutical form / generic medicinal products / similar biological medicinal product / reference medicinal product / biotechnology-derived product / proposed manufacturing process / manufacturing changes / biological products / given product / manufacturing consistency / biotechnology-derived proteins / analytical technologies / drug product / biological medicinal product / biosimilar product / chosen reference medicinal product / medicinal product / analytical tools / expression systems / biosimilar medicinal product / account state-of-the-art technology / medicinal products / similar biological medicinal products / manufacturing processes / Manufacturing process / /
Organization
World Health Organization / European Medicines Agency / Committee for Medicinal Products for Human Use / European Union / E-mail info@ema.europa.eu Website www.ema.europa.eu An / / /
Revised biosimilar quality guideline