earticle

영어

Regulatory environment encourage pharmaceutical company to develop biosimilar product and issued relevant guideline as a general principles to be applied and addressed for development of Biosimilar and also issued product specific guideline. Celltrion is major biosimilar developing player in monoclonal antibody area and already achieved outstanding progress. Celltrion took systematic strategy with global consulting group for IND submission via scientific advisory meeting with EMA and local regulatory agencies. The presentation includes trends of biosimilar development, regulatory environment, Celltrion's approach and case study of our leading biosimilar project.