Time Is Ripe For Global Action On Orphan Biosimilars
Executive Summary
European industry association wants global convergence on development requirements, though the European Medicines Agency says that this would prove challenging.
You may also be interested in...
Can Biosimilar Orphans Increase Health System Sustainability In The UK?
Developing biosimilar orphan drugs is fraught with challenges and needs buy-in from regulators, developers, patients and clinicians.
Regulators Call for More Harmonization On Ultra-Rare ATMPs
Early discussions between companies and multiple regulators could drive greater alignment among jurisdictions.
Can The UK Remain A First Launch Market?
More pollical support from the National Health Service and health ministers is needed to ensure the UK’s future as a desirable launch market.