Questions and Answers on biosimilar development published by China CDE: Part I
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. Q1: The scope of ‘biosimilars’ A1: ‘Biosimilars’ applies to the therapeutic recombinant protein products with a…