Time Is Ripe For Global Action On Orphan Biosimilars
European industry association wants global convergence on development requirements, though the European Medicines Agency says that this would prove challenging.
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Developing biosimilar orphan drugs is fraught with challenges and needs buy-in from regulators, developers, patients and clinicians.
Early discussions between companies and multiple regulators could drive greater alignment among jurisdictions.
More pollical support from the National Health Service and health ministers is needed to ensure the UK’s future as a desirable launch market.