A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager practices and federal reimbursement policies that it says are threatening the long-term sustainability of the generic and biosimilar markets.
Human Drugs
Priority Review for Roche Enspryng sBLA
FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease, an autoimmune disease with no approved treatments.
