1. Guidance on scientific considerations in demonstrating biosimilarity to a reference product;FDA,2015
2. Guidance on statistical approaches to evaluate analytical similarity;FDA,2017
3. Analytical similarity assessment in biosimilar studies;Chow;AAPS J.,2016
4. Development of statistical methods for analytical similarity assessment;Tsong;J. Biopharm. Stat.,2017
5. Guidance on development of therapeutic protein biosimilar: comparative analytical assessment and other quality-related considerations;FDA,2019