EMA publishes single Q&A document for biosimilars submitted via centralised procedure
This article was originally published in SRA
Executive Summary
The European Medicines Agency has published a document designed to answer regulatory and procedural questions from companies using the centralised procedure to gain approval for their biosimilars1,2.
You may also be interested in...
Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
German HTA Queries Polivy Benefits Amid Lack Of Evidence
Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.
Germany Confirms No Reimbursement Status For ‘Lifestyle’ Drug Wegovy
In Germany Novo Nordisk’s obesity drug Wegovy will remain excluded from reimbursement for obesity, unlike Rhythm’s Imcivree.