Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Litigation
Patents
PipCast®
PTE
Webinars

FDA accepts Biogen aBLA for biosimilar tocilizumab (Genentech’s Actemra®)

Dec 9, 2022

Biogen announced that the FDA accepted its aBLA for BIIB800 (biosimilar tocilizumab) referencing Genentech’s Actemra®.  This follows the EMA acceptance of Biogen’s MAA for BIIB800 in September 2022. Tocilizumab is an anti-interleukin-6 receptor monoclonal antibody which is indicated for various health conditions including moderate to severe RA in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.

Print Page Mail Article