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

Formycon and Fresenius Kabi’s Stelara® (Ustekinumab) Biosimilar Submission Accepted by EMA

Sep 29, 2023

Formycon and its commercialisation partner Fresenius Kabi announced that the EMA has accepted for review their MAA for FYB202, biosimilar to Johnson & Johnson’s Stelara® (ustekinumab).

In February 2023, Fresenius Kabi and Formycon AG announced they had reached a global agreement to commercialise FYB202. Under the agreement, Fresenius has exclusive commercialisation rights in key global markets, whilst Formycon is responsible for development and registration.  Formycon acquired the rights to FYB202 from Athos in May 2022.