News about GMP/cGMP

03.08.2018

Biosimilars: WHO publishes Q&A draft

The World Health Organization (WHO) has prepared a new questions and answers document to clarify earlier biosimilar guidelines. It will provide answers to questions asked by regulators over the last eight years.

The questions and answers document contains 48 questions and will be updated regularly to address new developments and issues.

The questions are divided into the following subject areas:

Concept for licensing similar biotherapeutic products
Reference biotherapeutic products
Quality
Nonclinical evaluation
Clinical evaluation
Pharmacovigilance

The draft is open for consultation until 20 September 2018.

Source:

WHO

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