Sandoz responds to EMA Draft Revision of Biosimilar Development Guidelines
June 19, 2013 – Sandoz is pleased that the European Medicines Agency (EMA) has issued a draft revised guideline on non-clinical and clinical issues in biosimilar product development. Overall, the draft revised guideline demonstrates EMA’s continued worldwide leadership in biosimilar regulations by applying science in a risk-based manner that safeguards patient safety without compromising access to […]