Accord BioPharma Secures U.S. License for Golimumab Biosimilar BAT2506

Accord BioPharma, Inc., a U.S.-based division of Intas Pharmaceuticals, has revealed a new strategic partnership with Bio-Thera Solutions. This collaboration focuses on the commercialization of BAT2506, a biosimilar to Simponi® (golimumab), in the United States. BAT2506, developed by Bio-Thera, is a human monoclonal antibody that acts as a tumor necrosis factor-alpha (TNF-alpha) blocker, pivotal in treating various autoimmune disorders. The agreement grants Accord exclusive U.S. commercialization rights, while Bio-Thera retains responsibility for the product's development, manufacturing, and supply.

Simponi®, the reference biologic for BAT2506, is used to treat conditions such as moderate to severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severely active ulcerative colitis. In 2023, sales of Simponi® and its variant Simponi Aria® reached approximately $3.2 billion globally, highlighting a significant market opportunity for Accord BioPharma to enhance patient access to biologics and strengthen its presence in the immunology sector.

Chrys Kokino, the U.S. President of Accord BioPharma, emphasized the rapid expansion of their biosimilar portfolio, underscoring the company's strategy to collaborate with international partners to expedite the introduction of biosimilars in the U.S. market. With the U.S. biologics market projected to expand substantially, biosimilars like BAT2506 are expected to provide unique opportunities across the healthcare landscape, according to Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals.

Dr. Shengfeng Li, CEO of Bio-Thera, expressed satisfaction with the partnership, viewing it as a means to further their goal of increasing the availability of immunology biosimilars to U.S. patients. The alliance is set to leverage Accord's expertise in the American biosimilar market to maximize the potential reach of BAT2506.

Accord BioPharma is recognized for its commitment to delivering affordable and accessible therapies in oncology, immunology, and critical care. By focusing on patient-centric solutions, the company aims to enhance the patient experience and broaden access to a range of biologic medicines that were previously cost-prohibitive. Accord's goal is to establish one of the most comprehensive biosimilar portfolios in the industry.

Bio-Thera Solutions, headquartered in Guangzhou, China, is a biopharmaceutical company known for its innovative approaches in developing treatments for cancer, autoimmune, cardiovascular, and other severe diseases. The company is also dedicated to creating biosimilars for existing biologics, with multiple candidates currently in late-stage development and several already approved products in various markets.

This partnership between Accord BioPharma and Bio-Thera Solutions represents a significant step in expanding the availability of biosimilar treatments in the U.S., potentially transforming the landscape of biologic therapy by offering more cost-effective alternatives to patients in need.