1. FDA website: About the Center for Biologics Evaluation and Research: What Are “Biologics – Questions and Answers; www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm
2. EMA Biosimilar Medicines - Overview: Biosimilars in the EU: Information Guide for Healthcare Workers (February 2019); www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview#information-for-patients-and-healthcare-professionals-section
3. ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (October 1999); https://database.ich.org/sites/default/files/Q6A%20Guideline.pdf
4. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (March 1999); https://database.ich.org/sites/default/files/Q6B%20Guideline.pdf
5. ICH Q1A(R2) Stability Testing of New Drug Substances and New Drug Products (February 2003); https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf