Biosimilar guideline revamp allows use of non-EU comparator product
This article was originally published in SRA
Executive Summary
The European Medicines Agency has overhauled its overarching guideline on biosimilars, bringing it up to date and clarifying the principles and terminology of biosimilarity1,2. The revised document says that in some cases a biosimilar could be compared with a reference drug approved outside the EU, and that a biosimilar could exceptionally be authorised on the basis of a pharmacokinetic comparative study without the need for a comparative clinical efficacy study.
You may also be interested in...
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.