Questions and Answers on biosimilar development published by China CDE: Part II
On July 31st, China CDE has published 7 Questions and Answers on biosimilar development to industry on its website. It mentioned that these Q&As respond to the most-commonly-asked-questions from applicants, and these Q&As also describe CDE’s considerations and requirements. Q4: Consideration in immunogenicity assessment A4: Sponsors are encouraged to collect immunogenicity data in any clinical…