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
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.
Bio-Thera Solutions e Dr. Reddy's Laboratories hanno annunciato un accordo esclusivo di commercializzazione per due prodotti biosimilari: BAT2206 (proposto biosimilare di Stelara®) e BAT2506 (proposto biosimilare di Simponi®). Nell'ambito della partnership, Bio-Thera si occuperà dello sviluppo, della produzione e della fornitura, mentre Dr. Reddy's (RDY) gestirà le approvazioni regolatorie e la commercializzazione nei territori del Sud-est asiatico, inclusi Cambogia, Indonesia, Malesia, Filippine, Thailandia e Vietnam.
Inoltre, Dr. Reddy's ha ottenuto diritti commerciali esclusivi per BAT2206 in Colombia. Questo segna la prima partnership di Bio-Thera focalizzata esclusivamente sul Sud-est asiatico, con l'obiettivo di ampliare l'accesso a farmaci a prezzi accessibili nei mercati emergenti.
Bio-Thera Solutions y Dr. Reddy's Laboratories han anunciado un acuerdo exclusivo de comercialización para dos productos biosimilares: BAT2206 (biosimilar propuesto de Stelara®) y BAT2506 (biosimilar propuesto de Simponi®). En el marco de la asociación, Bio-Thera se encargará del desarrollo, la fabricación y el suministro, mientras que Dr. Reddy's (RDY) gestionará las aprobaciones regulatorias y la comercialización en los territorios del Sudeste Asiático, incluyendo Camboya, Indonesia, Malasia, Filipinas, Tailandia y Vietnam.
Además, Dr. Reddy's ha asegurado derechos comerciales exclusivos para BAT2206 en Colombia. Esta es la primera asociación de Bio-Thera centrada exclusivamente en el Sudeste Asiático, con el objetivo de ampliar el acceso a medicamentos asequibles en los mercados emergentes.
Bio-Thera Solutions와 Dr. Reddy's Laboratories는 두 가지 바이오시밀러 제품에 대한 독점 상업화 계약을 발표했습니다: BAT2206 (제안된 Stelara® 바이오시밀러) 및 BAT2506 (제안된 Simponi® 바이오시밀러). 파트너십에 따라 Bio-Thera는 개발, 제조 및 공급을 담당하고, Dr. Reddy's (RDY)는 동남아시아 지역의 규제 승인 및 상업화를 관리합니다. 이 지역에는 캄보디아, 인도네시아, 말레이시아, 필리핀, 태국 및 베트남이 포함됩니다.
추가로, Dr. Reddy's는 콜롬비아에서 BAT2206에 대한 독점 상업적 권리를 확보했습니다. 이는 Bio-Thera가 동남아시아에 집중한 첫 번째 파트너십으로, 신흥 시장에서 저렴한 의약품에 대한 접근을 확대하는 것을 목표로 하고 있습니다.
Bio-Thera Solutions et Dr. Reddy's Laboratories ont annoncé un accord exclusif de commercialisation pour deux produits biosimilaires : BAT2206 (biosimilaire proposé de Stelara®) et BAT2506 (biosimilaire proposé de Simponi®). Dans le cadre de ce partenariat, Bio-Thera s'occupera du développement, de la fabrication et de l'approvisionnement, tandis que Dr. Reddy's (RDY) gérera les approbations réglementaires et la commercialisation dans les territoires du Sud-Est asiatique, y compris le Cambodge, l'Indonésie, la Malaisie, les Philippines, la Thaïlande et le Vietnam.
De plus, Dr. Reddy's a obtenu des droits commerciaux exclusifs pour BAT2206 en Colombie. Cela marque le premier partenariat de Bio-Thera axé exclusivement sur le Sud-Est asiatique, visant à élargir l'accès à des médicaments abordables sur les marchés émergents.
Bio-Thera Solutions und Dr. Reddy's Laboratories haben eine exklusive Vermarktungsvereinbarung für zwei biosimilar Produkte angekündigt: BAT2206 (vorgeschlagenes Biosimilar von Stelara®) und BAT2506 (vorgeschlagenes Biosimilar von Simponi®). Im Rahmen der Partnerschaft wird Bio-Thera die Entwicklung, Herstellung und Lieferung übernehmen, während Dr. Reddy's (RDY) die behördlichen Genehmigungen und die Vermarktung in den Südostasiatischen Gebieten, einschließlich Kambodscha, Indonesien, Malaysia, Philippinen, Thailand und Vietnam, verwalten wird.
Darüber hinaus hat Dr. Reddy's exklusive Handelsrechte für BAT2206 in Kolumbien gesichert. Dies markiert die erste Partnerschaft von Bio-Thera, die sich ausschließlich auf Südostasien konzentriert, mit dem Ziel, den Zugang zu erschwinglichen Medikamenten in Schwellenländern zu erweitern.
- Expansion into new emerging markets in Southeast Asia
- Strategic partnership for commercialization of two biosimilar products
- Potential revenue growth through access to multiple territories
- Development and manufacturing costs remain with Bio-Thera
- Regulatory approval process pending in all territories
Insights
This partnership marks a strategic expansion for Dr. Reddy's in the competitive biosimilar market across Southeast Asia and Colombia. By licensing commercial rights to BAT2206 (ustekinumab biosimilar) and BAT2506 (golimumab biosimilar), Dr. Reddy's gains access to two potentially valuable assets that target high-value immunology indications without shouldering development costs.
The deal structure is notably efficient - Bio-Thera handles the capital-intensive aspects (development, manufacturing, supply chain) while Dr. Reddy's leverages its established commercial infrastructure in emerging markets to handle regulatory approvals and commercialization. This asset-light approach for Dr. Reddy's enables portfolio expansion with controlled R&D expenditure.
Stelara® (ustekinumab) generated approximately
The Southeast Asian pharmaceutical market is projected to grow at a
This partnership significantly enhances Dr. Reddy's competitive position in the high-growth immunology biosimilar space across Southeast Asia. The company is acquiring commercial rights to two biosimilars targeting blockbuster originator products with combined annual sales exceeding
BAT2206 (ustekinumab biosimilar) represents a particularly valuable asset as Stelara® is Johnson & Johnson's top-selling product with applications across multiple inflammatory conditions. Notably, Stelara® began facing biosimilar competition in the EU in 2023 and will face US competition in 2025, making this a timely market entry strategy for emerging regions.
BAT2506 (golimumab biosimilar) targets Simponi®, which despite smaller market size, still represents a significant opportunity as one of the preferred TNF-alpha inhibitors with monthly dosing advantages.
The arrangement leverages complementary strengths: Bio-Thera's established biosimilar development capabilities (evidenced by their successful adalimumab and bevacizumab biosimilars) combined with Dr. Reddy's robust commercial infrastructure across Southeast Asian markets that typically lack domestic biologics manufacturing capability.
This deal follows industry trends of geographic segmentation in biosimilar licensing, focusing on regions where Dr. Reddy's has established channels and regulatory expertise. For price-sensitive Southeast Asian markets where biologics penetration remains low due to cost barriers, these biosimilars could significantly expand patient access to critical immunology therapies while providing Dr. Reddy's with revenue growth in its strategic emerging markets.
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
"This is our first partnership focused solely on
M.V. Ramana, CEO – Branded Markets (
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
About Bio-Thera Solutions:
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou,
About Dr. Reddy's:
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in
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.
- Stelara® and Simponi® is a registered trademark of Johnson & Johnson
- QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
- TOFIDENCETM is a trademark of Biogen MA Inc.
- Avzivi® is a registered trademark of Sandoz AG
- 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