FDA ,insülin biyobenzerlerin onay ve kullanıma girişini hızlandıracak yeni yolları planlıyor.
FDA enacts abbreviated approval pathway for insulin biosimilars
Effective today, the FDA institutes a shortened regulatory pathway for certain biologics, including insulin and human growth hormone, that hitherto had been classified as drugs. The agency will consider future marketing applications for said products as biologics license applications (BLA) which will allow for faster approvals compared to the generic drug pathway while promoting increased competition.
