Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Scientific guideline
HumanScientific guidelines
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The guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005 Rev1) will need revision in light of the EMA reflection paper on a tailored clinical approach in biosimilar development. The reflection paper introduces a risk-based, tailored framework that may allow for the waiver or modification of comparative clinical efficacy studies where sufficient evidence of biosimilarity can be derived from analytical and pharmacokinetic/pharmacodynamic data.
Pending the completion of this revision, the guideline EMEA/CHMP/BMWP/42832/2005 Rev1 should be considered fully applicable only in those cases where a tailored approach to comparative clinical efficacy studies is not feasible — i.e., where the available data do not support a waiver or reduction of the comparative efficacy trial in accordance with the principles set out in the reflection paper. Applicants are encouraged to consult the reflection paper and to seek scientific advice from EMA when determining the most appropriate clinical development strategy for their biosimilar product.
Keywords: Similar biological medicinal product, recombinant proteins, non-clinical studies, clinical studies, safety, pharmacovigilance, immunogenicity