Bio-Thera and Dr. Reddy's Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara® Biosimilar, and BAT2506, a Proposed Simponi® Biosimilar, for Southeast Asia

Rhea-AI Summary

Bio-Thera Solutions and Dr. Reddy's Laboratories have announced an exclusive commercialization agreement for two biosimilar products: BAT2206 (proposed Stelara® biosimilar) and BAT2506 (proposed Simponi® biosimilar). Under the partnership, Bio-Thera will handle development, manufacturing, and supply, while Dr. Reddy's (RDY) will manage regulatory approvals and commercialization in Southeast Asian territories including Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam.

Additionally, Dr. Reddy's has secured exclusive commercial rights for BAT2206 in Colombia. This marks Bio-Thera's first partnership focused exclusively on Southeast Asia, aiming to expand access to affordable medicines in emerging markets.

Positive

• Expansion into new emerging markets in Southeast Asia
• Strategic partnership for commercialization of two biosimilar products
• Potential revenue growth through access to multiple territories

Negative

• Development and manufacturing costs remain with Bio-Thera
• Regulatory approval process pending in all territories

GUANGZHOU, China and HYDERABAD, India, March 27, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH; "Bio-Thera"), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy's"), announce today they have reached commercialization and license agreements for BAT2206, a proposed Stelara^® biosimilar, and BAT2506, a proposed Simponi^® biosimilar.

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506. Dr. Reddy's will be responsible for seeking regulatory approvals as well as commercialization in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, Philippines, Thailand, Vietnam. In addition, Dr. Reddy's will also receive the exclusive commercial rights to BAT2206 in Colombia.

"This is our first partnership focused solely on Southeast Asia and Dr. Reddy's is the perfect partner to help bring BAT2206 and BAT2506 to patients in the region", said Dr. Shengfeng Li, CEO of Bio-Thera. "Bio-Thera believes in the health and welfare of patients around the world and this collaboration with Dr. Reddy's demonstrates our commitment to the patients in Southeast Asia."

M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy's, said: "Our partnership with Bio-Thera enables us to further expand our biosimilars offerings in the emerging markets. With our well-established commercial strengths in these markets, we look forward to addressing the unmet needs of patients with access to affordable medicines."

About BAT2206 (ustekinumab)
BAT2206 is a proposed biosimilar to Jansen's Stelara^® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases. In the EU, Stelara^® is currently approved for the treatment of 1) moderate to severe plaque psoriasis in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, 2) active psoriatic arthritis, alone or combined with methotrexate, in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs), 3) moderately to severely active Crohn's disease in adults whose condition has not improved enough with other treatments for Crohn's disease or who cannot receive such treatments, 4) moderately to severely active ulcerative colitis in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments.

About BAT2506 (golimumab)
BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab, a human monoclonal antibody, inhibits the biological activity of tumor necrosis factor alpha (TNF-alpha). Originator product Simponi^® is approved in the U.S. for moderate to severe rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis and moderate to severely active UC, and carries a Boxed Warning for Serious Infection and Malignancy.

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 four approved products: QLETLI^® and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE^®/ BAT1806 and Avzivi^® / Pobevcy^® in the US, EU 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 antibody-drug conjugates (ADCs). For more information, please visit www.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).

About Dr. Reddy's:
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information contained herein.

Bio-Thera Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to BAT2206, BAT2506 or the product pipelines in general 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. 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. Stelara^® and Simponi^® is a registered trademark of Johnson & Johnson
2. QLETLI^® is a registered trademark of Bio-Thera Solutions, Ltd.
3. TOFIDENCE^TM is a trademark of Biogen MA Inc.
4. Avzivi^® is a registered trademark of Sandoz AG
5. POBEVCY^® is a registered trademark of Bio-Thera Solutions, Ltd.

For further information:

Bio-Thera Contact:
Bert E. Thomas IV
Phone: +1.410.627.1734
Email: bethomas@bio-thera.com 

Dr. Reddy's Contacts:

Usha Iyer
Head of Corporate Communications
ushaiyer@drreddys.com

Richa Periwal
Head of Investor Relations
richaperiwal@drreddys.com 

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SOURCE Bio-Thera Solutions, Ltd

FAQ

What biosimilar products are included in the Bio-Thera and Dr. Reddy's (RDY) commercialization agreement?

The agreement covers BAT2206 (Stelara® biosimilar) and BAT2506 (Simponi® biosimilar).

Which Southeast Asian countries are covered in Dr. Reddy's (RDY) commercialization rights for BAT2206 and BAT2506?

The agreement covers Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam.

What are the responsibilities of Bio-Thera and Dr. Reddy's (RDY) in this biosimilar partnership?

Bio-Thera handles development, manufacturing, and supply, while Dr. Reddy's manages regulatory approvals and commercialization.

Does Dr. Reddy's (RDY) have commercial rights for these biosimilars in any other regions?

Yes, Dr. Reddy's has exclusive commercial rights for BAT2206 in Colombia, in addition to Southeast Asian territories.