GUANGZHOU, China - Bio-Thera Solutions (688177.SH), a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, announced that its partner, Biogen Inc. (Nasdaq: BIIB) officially launched TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA, in the United States. The U.S. Food and Drug Administration approved TOFIDENCE in September 2023 for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in the United States. At launch, TOFIDENCE is available in three vial sizes, 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, for intravenous infusion, with subcutaneous formulations to follow.

“Tofidence is the first product developed by Bio-Thera to launch in the US market” said Shengfeng Li, CEO at Bio-Thera. “This is a major milestone for Bio-Thera as a company and as a biosimilar developer that is committed to bringing affordable medicines to patients around the world.”

Biogen and Bio-Thera entered a commercialization and license agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, TOFIDENCE, developed by Bio-Thera, is commercialized by Biogen in the United States. Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau, and Taiwan).

About TOFIDENCE (tocilizumab- bavi)

TOFIDENCE (tocilizumab-bavi), is a treatment developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is indicated for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. 

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including three approved products: QLETLI? in China, and TOFIDENCE?/BAT1806 and Avzivi?/Pobevcy? in the US and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs.

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Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to products and businesses of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise.

1. TOFIDENCETM is a registered trademark of Biogen, MA Inc.

2. QLETLI? is a registered trademark of Bio-Thera Solutions, Ltd.

3. AVZIVI? is a registered trademark of Sandoz AG

4. POBEVCY? is a registered trademark of Bio-Thera Solutions, Ltd.