Time Is Ripe For Global Action On Orphan Biosimilars
Industry Urges Incentives And Tailored Pricing And Reimbursement Policies
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.
International reference pricing is becoming more irrelevant as increasing emphasis is placed on other cost-containment measures.
Early discussions between companies and multiple regulators could drive greater alignment among jurisdictions.