#China #Guangzhou #BAT2206 #Bio-Thera Solutions #USYMRO

European Commission Approves Bio-Thera Solutions' USYMRO®

On August 26, 2025, Bio-Thera Solutions Inc., a Guangzhou-based biopharmaceutical firm, announced a major achievement: the approval of its biosimilar product BAT2206, known as USYMRO®, by the European Commission (EC). This important development comes after receiving a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA's CHMP) on June 19, 2025. The significance of this approval cannot be understated as it marks Bio-Thera's third product to receive endorsement within the European market.

The Significance of USYMRO®

USYMRO® is a biosimilar to Janssen's Stelara®, an established treatment that has served numerous patients in managing severe autoimmune diseases. The approval positions USYMRO® as a critical treatment option for patients suffering from conditions such as psoriasis, psoriatic arthritis (PsA), and Crohn's disease (CD). This medication employs a human monoclonal antibody mechanism that inhibits the bioactivity of both IL-12 and IL-23, key cytokines involved in inflammatory processes. By obstructing these pathways, USYMRO® aims to alleviate symptoms and improve the quality of life for patients faced with chronic inflammatory disorders.

Shengfeng Li, the CEO of Bio-Thera, expressed excitement about this regulatory success. He stated, "The EC approval of BAT2206 is another significant accomplishment for Bio-Thera as it marks the third EC approved product for our company. We are committed to expanding access for patients in Europe to important treatments through the continued development of our growing biosimilar pipeline of approved products." This commitment underscores Bio-Thera's ongoing dedication to increasing treatment accessibility across Europe.

Partnership with Gedeon Richter

Bio-Thera has formed a strategic alliance with Gedeon Richter, securing a license and commercialization agreement for USYMRO® in October 2024. According to this collaboration, Bio-Thera will oversee the development and production of USYMRO®, while Gedeon Richter will manage its exclusive distribution throughout the EU, UK, Switzerland, and several other select markets. Such partnerships are essential in the biopharmaceutical industry, ensuring that innovative therapies can reach patients effectively and efficiently.

Bio-Thera's Innovations and Pipeline

Established as a leader in innovative therapies, Bio-Thera Solutions is dedicated to addressing major healthcare needs through its research and development efforts. The company specializes in creating both novel therapeutics and biosimilars for an array of conditions. In addition to USYMRO®, Bio-Thera's portfolio includes several other approved products, such as QLETLI® (adalimumab) and the recently launched STARJEMZA® (ustekinumab) in the US. The firm is currently advancing over 20 promising candidates through clinical trials, particularly focusing on immuno-oncology and targeted therapies.

Bio-Thera's robust R&D initiatives emphasize the importance of biosimilars—allowing for more affordable treatment options that uphold therapeutic efficacy, thereby expanding accessibility to critical therapies for patients.

Future Prospects

The approval of USYMRO® not only paves the way for further innovations within Bio-Thera's product pipeline but also highlights the increasing trend of biosimilars in the global market. With a strong commitment to quality and efficacy, the company's forward-looking strategies and collaborations aim to address the unmet needs of patients dealing with chronic and complex diseases.

As the healthcare landscape evolves, Bio-Thera Solutions is poised to remain at the forefront of biopharmaceutical development, ensuring that patients have access to effective treatment options. As they move ahead, the commitment to transparency and patient care will remain central to their operations—a critical factor as they navigate the opportunities and challenges presented by the biopharmaceutical industry.