Daeseok Choi, PhD CELLTRION, Inc.

Dr. Choi has been working at CELLTRION since 2015 in the Regulatory Affairs team, responsible for the preparation and submission of regulatory dossiers, in particular CMC documents, of biosimilars, and communication with the agencies including FDA. He has been involved in the preparation and review of module 3 documents and responses to the agency’s questions, and dedicated himself for the approval of a infliximab biosimilar, Inflectra in US and a trastuzumab biosimilar, Herzuma in Europe. Today, Dr. Choi manages the group responsible for regulatory activities to seek the approval of Herzuma in US.