Ustekinumab

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. Continue Reading 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 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 BAT2 5 06 ( 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 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: . 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: [email protected] Dr. Reddy's Contacts: Usha Iyer Head of Corporate Communications [email protected] Richa Periwal Head of Investor Relations [email protected] SOURCE Bio-Thera Solutions, Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

STEQEYMA® (ustekinumab-stba) is Celltrion's biosimilar to STELARA® (ustekinumab), which was launched on March 12, 2025 Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program in August 2024 Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program in August 2024 JERSEY CITY, N.J., March 27, 2025 - Celltrion, Inc., today announced that STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab) has been added to the Costco Member Prescription Program. "We're focused on improving affordability and access to a widely used, high-cost treatment for a variety of inflammatory conditions," said Francine Galante, Vice President of Market Access at Celltrion USA. "The addition of STEQEYMA to the Costco Member Prescription Program together with adalimumab-aaty will help us deliver our commitment to lowering financial barriers and improving access to critical treatments." STEQEYMA is available in both subcutaneous injection and intravenous infusion and is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn's disease (CD) and ulcerative colitis (UC) in adult patients. The Costco Member Prescription Program is a prescription drug discount card program offered by Costco Health Solutions that provides eligible Costco members and their eligible dependents the ability to obtain lower prices on STEQEYMA and other participating drugs at Costco Specialty Pharmacies and at participating pharmacies. "By partnering with Costco Health Solutions once again, we are able to help even more Americans lower the price of their prescriptions, given the fact that Stelara ranks as one of the most expensive prescription drugs on the market," said Tom Nusbickel, Chief Commercial Officer at Celltrion USA. STEQEYMA will be available in the U.S. from Costco Specialty Pharmacies on April 1st, 2025, for self-funded employer plans and Costco members who are uninsured and want to pay cash for their STEQEYMA prescription or who have been denied coverage by their insurers. Notes to Editors: About STEQEYMA® (ustekinumab-stba) STEQEYMA®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONS STEQEYMA® (ustekinumab-stba) is indicated for the treatment of: Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Psoriatic Arthritis (PsA) in adults and pediatric patients 6 years of age and older with active psoriatic arthritis. Crohn's Disease (CD) in adult patients with moderately to severely active Crohn's disease. Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis. IMPORTANT SAFETY INFORMATION STEQEYMA® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA. Serious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious or clinically significant infection develops, discontinue STEQEYMA until the infection resolves. Serious infections from mycobacteria, salmonella, and BCG vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. Evaluate patients for TB prior to starting STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA. Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Monitor all patients receiving STEQEYMA for signs of malignancies. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA. If Posterior Reversible Encephalopathy Syndrome (PRES) is suspected, treat promptly and discontinue STEQEYMA. Avoid use of live vaccines in patients during treatment with STEQEYMA. Non-live vaccinations received during STEQEYMA treatment may not elicit enough immune response to prevent disease. If diagnosis of noninfectious pneumonia is confirmed, discontinue STEQEYMA and institute appropriate treatment. The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were:Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue. CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. UC: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue. CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. UC: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. For more information, see Full Prescribing Information. About Celltrion Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has ten biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks STELARA® is a registered trademark of Johnson & Johnson. STEQEYMA® is a registered trademark of Celltrion, Inc., used under license.