Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

FDA accepts ABLA for natalizumab biosimilar

Jul 25, 2022

Sandoz announced that the FDA has accepted its ABLA for a natalizumab biosimilar developed by Polpharma Biologics for all indications covered by the reference medicine Tysabri® including relapsing forms of multiple sclerosis (MS) – clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease in adults – and Crohn´s Disease.  The EMA accepted a MAA for the same product earlier this month.