Bio-Thera Solutions announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for USYMRO® (ustekinumab), a biosimilar monoclonal antibody referencing Stelara®. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for USYMRO®.
"Bio-Thera is committed to being one of the premier biosimilar developers and manufacturers in the world," said Shengfeng Li, CEO of Bio-Thera Solutions. "The positive CHMP recommendation for USYMRO® builds on Bio-Thera's track record of accomplishment as a biosimilar developer and manufacturer."
This positive CHMP opinion on USYMRO® was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of USYMRO® was conducted and supports biosimilarity with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of USYMRO® with both the EU and US reference product in healthy volunteers. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared USYMRO® with the reference product to confirm equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with severe plaque psoraisis. The totality of evidence demonstrated USYMRO® is a biosimilar of the reference biologic.
Bio-Thera and Gedeon Richter entered into a license and commercialization agreement for USYMRO® (BAT2206) in October of 2024. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Gedeon Richter will have the right to commercialize the medicine upon approval and successful Marketing Authorization Holder Transfer in the EU, the UK and Switzerland.
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