Bio-Thera Solutions Advances with USYMRO® Biosimilar Approval
Bio-Thera Solutions Achieves CHMP Positive Opinion for USYMRO®
Bio-Thera Solutions Inc. (688177:SH), an innovative biopharmaceutical company, has made remarkable strides by receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for USYMRO® (ustekinumab). This decision is based on comprehensive analytical, non-clinical, and clinical data that firmly establish USYMRO® as a biosimilar to the reference product, Stelara®.
The Evaluation Process Behind USYMRO®
The CHMP's positive opinion is a significant milestone for Bio-Thera Solutions as it reflects the company's extensive commitment to biosimilarity development. The evaluation process involved an extensive examination of the drug's analytical characterization, as well as its physical, chemical, and biological properties, supporting its comparability to Stelara®. This thorough investigation included a randomized double-blind, single-dose Phase 1 study that successfully compared USYMRO® with both the EU and US versions of the reference product, ensuring that the safety, immunogenicity, and pharmacokinetics of USYMRO® align with established standards.
Results from Clinical Studies
In addition to the Phase 1 study, a comprehensive Phase 3 study was conducted, involving multiple doses in a three-arm parallel group design. This research aimed to evaluate the efficacy of USYMRO® compared to Stelara® in patients suffering from severe plaque psoriasis. The outcomes demonstrated that USYMRO® exhibited equivalent efficacy while maintaining comparable safety and immunogenicity profiles, reinforcing its status as a biosimilar to Stelara®.
Strategic Partnerships Enhance Development
In light of this positive development, Bio-Thera Solutions has also partnered with Gedeon Richter, entering into a licensing and commercialization agreement for USYMRO® (also known as BAT2206) in October of the previous year. This partnership delineates that Bio-Thera is responsible for the development and manufacturing processes, while Gedeon Richter will take charge of commercializing the product upon successful marketing authorization in various regions.
What is USYMRO®?
USYMRO® (ustekinumab) is a biosimilar to Janssen's Stelara®, designed to inhibit the bioactivity of human interleukin-12 (IL-12) and interleukin-23 (IL-23). These cytokines play a critical role in inflammatory processes. By preventing the binding of shared p40 subunits to IL-12 and IL-23 receptors, USYMRO® aims to mitigate chronic inflammation associated with conditions such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Bio-Thera Solutions: A Leader in Biopharmaceutical Innovation
Operating from Guangzhou, China, Bio-Thera Solutions is at the forefront of developing innovative therapies targeting various medical needs. The company specializes not only in biosimilars but also in new therapeutic developments for diseases that range from cancer to autoimmune and cardiovascular conditions. Bio-Thera has successfully advanced multiple candidates into late-stage development and boasts a portfolio of approved products including QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate).
The Future of Bio-Thera Solutions
With more than 20 promising candidates undergoing clinical trials, Bio-Thera Solutions is poised to contribute significantly to the biopharmaceutical sector. The focus includes ventures in immuno-oncology and the development of targeted therapies, such as antibody-drug conjugates that harness the unique properties of antibodies to deliver therapeutic agents directly to cancer cells.
Frequently Asked Questions
What is USYMRO®?
USYMRO® is a biosimilar referencing Stelara®, designed to treat chronic inflammatory diseases by inhibiting IL-12 and IL-23.
What does CHMP's positive opinion mean for Bio-Thera Solutions?
This opinion signifies regulatory approval for marketing USYMRO® in the EU, enhancing Bio-Thera's position in biopharmaceutical development.
Who are the partners involved with USYMRO®?
Bio-Thera has partnered with Gedeon Richter for the licensing and commercialization of USYMRO® across various territories.
What types of diseases can USYMRO® help treat?
USYMRO® is indicated for conditions such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
How is Bio-Thera Solutions advancing in the biopharmaceutical field?
Bio-Thera is focused on innovative therapies, offering multiple candidates in late-stage development along with several approved products.
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