Module 5 Presentations

05/07/2024

Biotech Products

• The Guideline on Virus Safety Evaluation of Biotechnological IMPs (EMEA/CHMP/BWP/398498/05) outlines considerations for biotech viral safety • May be presented in Annex or incorporated into the body text of the DS section

21

Biosimilars Three overarching quality guidelines, several product specific. • Guideline on similar biological medicinal products containing biotech derived proteins as active substances Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues Often quality considerations collated as a “regional module”. • •

Reproduced from EMA, accessed Nov-2020

22