As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…
On August 25, 2023, Sandoz announced that the FDA has approved its biosimilar TYRUKO® (natalizumab-sztn), developed by Polpharma Biologics. TYRUKO® injection is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). TYRUKO® is also indicated for inducing and maintaining clinical response and remission in adult patients…