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.

Selected tickers: Eli Lilly (LLY -2.4%), Novo Nordisk (NVO +2.2%), Sanofi (SNY +2.6%), Teva Pharmaceutical Industries (TEVA +4.5%), Mylan (MYL +2%)

https://seekingalpha.com/news/3554323-fda-enacts-abbreviated-approval-pathway-for-insulin-biosimilars