Shots:
- The CHMP has recommended Usymro (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product
- Opinion was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK & immunogenicity of Usymro vs US & EU Stelara
- 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
Ref: Prnewswire | Image: Biothera| Press Release
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