Bio-Thera Secures the EC’s Approval for Usymro (Biosimilar, Stelara)
Shots:
- The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference product
- In Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU, UK, & Switzerland
- Ustekinumab is a fully human anti-IL-12/IL-23 mAb indicated for the treatment of autoimmune diseases incl. plaque psoriasis, psoriatic arthritis & Crohn’s disease
Ref: PRNewswire | Image: Bio-Thera | Press Release
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