Event Information

Time：May 18, 2015 (Monday)
Place：TFDA

The discussion meeting about the Guidelines on the Review and Approval of Biosimilars (draft) was moderated by Dr. Shih-Chih Tsai of the TFDA. Experts, including Dr. Chyong-Huey Lai, Dr. Min-Hsiung Lin, Dr. Tsang-Wu Liu, Dr. Zhao-lian Huang and Dr. Li-Heng Pao, and representatives of pharmaceutical associations were invited to attend this meeting.

The panel discussed the principles, general rules, quality issues and non-clinical and clinical issues of this draft. Questions and comments made by pharmaceutical associations were discussed and answered. This meeting was only about the Guidelines for biosimilars. The discussion did not extend to the Guidelines for biosimilar monoclonal antibody (biosimilar m ab) as announced in 2013. A separate discussion meeting will be arranged. The experts suggested incorporating an advisory mechanism into the Guidelines. Please refer to the attachments for the replies to the industry’s comments and the meeting minutes.