Comparative studies of biosimilar drugs

Selvita experienced team possesses an extensive expertise in the comparability studies of biosimilar medicinal products and provides a wide range of support in method development, method validation and routine testing of biopharmaceutical products. All studies are designed, optimized and performed based on the EMA and ICH guidelines, as well as European and US Pharmacopoieas. Selvita has established an extensive set of in-house tests suggested by the ICH Q6B guideline to perform during biopharmaceuticals’ characterization.