Bio-Thera Solutions Receives Positive CHMP Opinion for Ustekinumab Biosimilar USYMRO
核心洞察
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use adopted a positive opinion for USYMRO (ustekinumab), Bio-Thera Solutions (搜索)' biosimilar referencing Stelara.
The positive recommendation was based on comprehensive analytical, non-clinical and clinical data demonstrating biosimilarity through Phase 1 and Phase 3 studies in healthy volunteers and severe plaque psoriasis (搜索) patients.
Bio-Thera partnered with Gedeon Richter in October 2024 for commercialization rights in the EU, UK and Switzerland following potential European Commission approval.
Bio-Thera Solutions (搜索) Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (搜索) 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 (搜索). "The positive CHMP recommendation for USYMRO builds on Bio-Thera's track record of accomplishment as a biosimilar developer and manufacturer."
Clinical Development Program
The positive CHMP opinion 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.
The clinical development program included a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study that compared the pharmacokinetics, safety and immunogenicity of USYMRO with both the EU and US reference product in healthy volunteers. Additionally, 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 psoriasis (搜索).
Commercialization Partnership
Bio-Thera and Gedeon Richter entered into a license and commercialization agreement for USYMRO (BAT2206) in October 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.
Mechanism of Action and Therapeutic Applications
USYMRO is a biosimilar to Janssen's Stelara which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 (搜索) and IL-23 (搜索) by preventing shared p40 subunit from binding to the IL-12Rβ1 (搜索) receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of immune cells.
IL-12 (搜索) and IL-23 (搜索) are involved in inflammatory and immune responses, such as natural killer cell activation, CD4+ T-cell differentiation and following relative cytokines stimulated release. Abnormal regulation of IL-12 and IL-23 have been implicated as important contributors to chronic inflammation, including psoriasis (搜索), psoriatic arthritis (搜索) (PsA), Crohn's disease (搜索) (CD), and ulcerative colitis (搜索) (UC). Neutralizing human IL-12 and IL-23 by USYMRO to prevent the relevant cell signaling in the Th1 or Th17 lineages can effectively block the pathologic processes of these immune disorders.
Company Profile
Bio-Thera Solutions (搜索), Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases.
As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI (adalimumab) and BETAGRIN (bevifibatide citrate) Injection in China, STARJEMZA in the US, and BAT1806/TOFIDENCE (tocilizumab) and AVZIVI (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs).