Bio-Thera Solutions Achieves Positive CHMP Opinion
Bio-Thera Solutions Inc., a biopharmaceutical company based in Guangzhou, China, has received an encouraging recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for their product, USYMRO® (ustekinumab). This biosimilar is referenced from the established medication, Stelara®, which is known for its effectiveness in various autoimmune diseases.
CHMP's Support and Its Significance
The CHMP's positive opinion for USYMRO® marks a pivotal moment for Bio-Thera, as it highlights the extensive research and development undertaken by the company. This decision is built on a robust set of analytical, non-clinical, and clinical data that supports the similarity of USYMRO® to Stelara®. The opinion will now be forwarded to the European Commission to decide on the marketing authorization, a step that could allow USYMRO® to become an accessible treatment option for patients in need.
Shengfeng Li, the CEO of Bio-Thera Solutions, expressed the company's commitment to being a leading player in the global biosimilar market, emphasizing the group's track record and dedication to excellence in the development of biosimilars.
Evidence for Biosimilarity: What It Entails
The favorable recommendation by the CHMP is not simply a matter of desire; it rests on a comprehensive body of evidence. Bio-Thera conducted a thorough analytical characterization of USYMRO®, examining its structural, physicochemical, and biological properties. This meticulous process aimed to demonstrate that USYMRO® adequately matches the reference product, Stelara®.
Furthermore, clinical trials played a crucial role in showcasing the biosimilarity of USYMRO®. A randomized, double-blind, single-dose, three-arm Phase 1 study included healthy volunteers to assess pharmacokinetics, safety, and immunogenicity, comparing USYMRO® to the reference products from both the EU and US. Additionally, a pivotal Phase 3 trial reaffirmed the biosimilar's efficacy and safety profiles in patients suffering from severe plaque psoriasis, confirming its potential as a viable treatment alternative.
The Joint Venture: License and Commercialization Agreement
In October 2024, Bio-Thera Solutions formed an agreement with Gedeon Richter regarding the license and commercialization of USYMRO® (known as BAT2206). This partnership outlines that Bio-Thera will be responsible for the product development and manufacturing process. After obtaining approval, Gedeon Richter will manage the commercialization of USYMRO® in multiple European markets, including the UK and Switzerland.
Understanding USYMRO®
USYMRO® is a biosimilar to Janssen's Stelara®, which functions as a human monoclonal antibody targeting interleukins IL-12 and IL-23. These interleukins play significant roles in various immune responses, influencing conditions like psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. By neutralizing IL-12 and IL-23, USYMRO® aims to impede the inflammatory pathways associated with such disorders, promising significant therapeutic benefits for patients.
Bio-Thera Solutions: A Leader in Biopharmaceuticals
Established as an innovative biopharmaceutical entity, Bio-Thera Solutions is committed to addressing severe unmet medical needs across diverse therapeutic areas, including oncology and autoimmune diseases. The company boasts five approved products including QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, and continues to advance its developmental pipeline, focusing on both established biosimilars and cutting-edge therapeutics.
As Bio-Thera prepares for potential market introduction of USYMRO®, the company remains poised to make a considerable impact in the field of biosimilars and address the evolving needs of patients seeking effective treatments.
For further details on Bio-Thera Solutions and its groundbreaking work, visit
Bio-Thera Solutions or follow them on social media platforms like X (@bio_thera_sol).
Cautionary Note on Forward-Looking Statements
As with any company in the biopharmaceutical sector, Bio-Thera Solutions warns that reliance on statements regarding future developments, including the success of USYMRO®, entails certain risks and uncertainties inherent in pharmaceutical research and development processes. The company emphasizes that actual future outcomes may differ from anticipated results due to various factors, including regulatory challenges and market dynamics.