Champion Industries' Bio-Thera Solutions Gains Positive EMA Opinion for USYMRO® Biosimilar Approval
- Bio-Thera Solutions receives positive EMA opinion for biosimilar USYMRO®, indicating strong data on its safety and efficacy.
- The company partners with Gedeon Richter for commercialization of USYMRO® in the EU, UK, and Switzerland post-approval.
- USYMRO® aims to improve patient access to affordable treatments for severe plaque psoriasis and other inflammatory conditions.
Bio-Thera Solutions Advances Biosimilar Market with USYMRO® Approval Recommendation
Bio-Thera Solutions Inc. achieves a significant milestone in the biopharmaceutical sector as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) delivers a positive opinion for its biosimilar monoclonal antibody, USYMRO® (ustekinumab). This product, which references the well-established drug Stelara®, is poised for further evaluation for marketing authorization by the European Commission. The recommendation stems from an extensive data package demonstrating USYMRO®’s biosimilarity to both EU and US reference products, showcasing its pharmacokinetics, safety, and immunogenicity through rigorous analytical, non-clinical, and clinical studies.
The Phase 1 study conducted by Bio-Thera confirms USYMRO®’s equivalence to the reference products in healthy volunteers, while a subsequent Phase 3 study highlights its comparable efficacy and safety for patients suffering from severe plaque psoriasis. These findings underscore the potential of USYMRO® to address unmet medical needs in the treatment of inflammatory conditions. Bio-Thera's CEO, Shengfeng Li, emphasizes the importance of this recommendation, reflecting the company's commitment to advancing biosimilar development and manufacturing capabilities. As the industry moves towards more affordable biologics, USYMRO® stands to make a meaningful impact on patient care and healthcare costs.
In October 2024, Bio-Thera entered into a strategic licensing and commercialization agreement with Gedeon Richter for USYMRO®. Under this partnership, Bio-Thera will manage the development and manufacturing processes, while Gedeon Richter will assume the commercialization rights post-approval in the EU, UK, and Switzerland. This collaboration highlights the growing trend of partnerships in the biopharmaceutical landscape, where companies leverage each other’s strengths to expedite product availability in competitive markets. The anticipated approval and subsequent market introduction of USYMRO® could significantly enhance patient access to effective treatments in the biosimilar sector.
In related developments, Partner Therapeutics, Inc. also secures EMA’s recommendation for their biosimilar IMREPLYS® (sargramostim), aimed at treating patients exposed to myelosuppressive radiation doses. The approval process is expected to conclude within 67 days, which could facilitate access across EU member states. This underscores a vital response to potential nuclear threats, emphasizing the importance of preparedness and effective medical interventions in crisis situations.
With these advancements, both Bio-Thera Solutions and Partner Therapeutics are positioned to capitalize on the growing demand for biosimilars, reflecting the continuous evolution of the biopharmaceutical industry towards more accessible therapeutic options for patients.
