STADA Arzneimittel AG

REYKJAVIK, Iceland, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes worldwide related to Alvotech’s biosimilar to Eylea® 2mg (aflibercept 40 mg/mL solution), which is approved for marketing in the European Economic Area, United Kingdom and Japan. In combination with the previously announced agreement which granted a Q4 2026 license entry date for the U.S., pending regulatory approval, Alvotech now has worldwide rights to manufacture and supply its global commercial partners with the aflibercept biosimilar. The settlement agreement allows Alvotech and its commercial partners to market and sell the biosimilar as of January 1, 2026 in the United Kingdom and Canada, as well as in Japan (excluding the diabetic macular edema indication) starting May 1, 2026 in the European Economic Area and all other countries in the world (other than the U.S.), and from November 1, 2026 in Japan with all approved indications. The remaining terms of the agreement remain confidential. “Following our previously announced settlement with the originator for the U.S. market we are delighted to resolve all outstanding patent-related matters in the rest of the world. Our strong regional commercial partners are now very well positioned for a successful launch. Aflibercept remains the established and widely used treatment for various retinal diseases and we look forward to continuing to support our commercial partners, further advancing the long-term sustainability of global healthcare systems,” said Robert Wessman, Chairman and CEO of Alvotech. Alvotech’s commercial partners for the Eylea biosimilar in Europe are Advanz Pharma (UK/EEA), STADA (DE) and Biogaran (FR), and for Japan Fuji Pharma Ltd. The biosimilar is approved by the European Commission for marketing in Europe under the tradenames Mynzepli® and Afiveg®. It is approved in the United Kingdom by the Medicines & Healthcare products Regulatory Agency (MHRA) under the tradename Mynzepli® and in Japan by the Japanese Ministry of Health, Labour and Welfare (MHLW) as Aflibercept BS. CONTACTS Media Benedikt Stefansson Sarah Macleod alvotech.media@alvotech.com Investors Balaji Prasad (US) Benedikt Stefansson (IS) Patrik Ling (SE) alvotech.ir@alvotech.com About AVT06 AVT06 is a biosimilar to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [1]. AVT06 has been approved under the brand names Mynzepli® (aflibercept) and Afiveg® (aflibercept) in the United Kingdom and European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan. Sources [1] Mynzepli® product information, https://www.ema.europa.eu/en/documents/product-information/mynzepli-epar-product-information_en.pdf Use of trademarks Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc. and Bayer AG. About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. Forward-Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Positive opinion from European Medicines Agency supports approval for golimumab biosimilar Gotenfia® developed by Bio-Thera and to be marketed by STADA Recommendation from EMA's CHMP committee is based on a robust analytical, non-clinical and clinical data package comparing the biosimilar candidate to the Simponi® reference product Bio-Thera is responsible for development, manufacturing and supply; STADA for commercialization in the EU, the UK, Switzerland and selected other countries BAD VILBEL, Germany and GUANGZHOU, China, Dec. 12, 2025 /PRNewswire/ -- Global specialty, generic and consumer healthcare medicines company STADA and Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today received a positive opinion from the European Medicines Agency (EMA), recommending approval for their Gotenfia® (golimumab) biosimilar candidate referencing Simponi®. Continue Reading The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission grant a marketing authorization for Gotenfia® for several chronic inflammatory autoimmune diseases: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and ulcerative colitis in adult patients, as well as juvenile idiopathic arthritis in for patients aged 2 years and older. Positive opinion from EMA supports approval for golimumab biosimilar Gotenfia® developed by Bio-Thera Post this The CHMP's positive opinion will now be referred for the European Commission to grant marketing authorization for the product that was developed by Bio-Thera under the code BAT2506. Following approval, the monoclonal antibody would be supplied as 50mg/0.5mL and 100mg/mL in a pre-filled syringe. The marketing authorization would apply across the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein. "This CHMP positive opinion marks a significant step towards bringing competition and improving patient access to a well-established anti-TNF therapy with annual European sales in the region of €700 million," commented STADA's Global Specialty Head, Ian Henshaw. "We look forward to employing STADA's almost 20 years of experience in supplying high-quality biosimilars in Europe ̵ not least adalimumab and ustekinumab in immunology ̵ to bring a convenient, once-monthly treatment option to rheumatologists, gastroenterologists and the patients they serve." "Bio-Thera is committed to being one of the premier biosimilar developers and manufacturers in the world," said Shengfeng Li, CEO of Bio-Thera Solutions. "Building on the strong presence we have established in the US through approvals and launches, this positive CHMP recommendation helps to establish Bio-Thera as a major biosimilar developer and manufacturer serving patients in Europe." The positive CHMP opinion on Gotenfia®/BAT2506 was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2506 was conducted and supports biosimilarity with the reference biologic product. A randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2506 with both the EU and US reference product in healthy volunteers. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared BAT2506 with the reference product in terms of efficacy, pharmacokinetic, safety and immunogenicity profiles, in psoriatic arthritis (PsA) patients. Based on the totality of evidence, it was demonstrated that BAT2506 is biosimilar to its reference product. Bio-Thera and STADA entered into a license and commercialization agreement for golimumab in May 2024. Under the terms of the agreement, Bio-Thera is responsible for the development, manufacturing and supply. STADA holds exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries. The two companies earlier this year announced an extension of their alliance to cover the immunosuppressant monoclonal antibody tocilizumab. About Gotenfia/ BAT2506 (golimumab) Gotenfia/BAT2506 is a proposed biosimilar to Simponi® which is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. About STADA Arzneimittel AG STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in over 100 countries. In financial year 2024, STADA achieved group sales of € 4,059 million and adjusted constant-currency earnings before interest, taxes, depreciation and amortization (adj. cc EBITDA) of € 886 million. As of 31 December 2024, STADA employed 11,649 people worldwide. 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 five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and USYMRO®(ustekinumab) in EU, and TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY® in 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). Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to 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, 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. STADA information for journalists STADA Arzneimittel AG - Media Relations Stadastrasse 2-18, 61118 Bad Vilbel - Germany Phone: +49 (0) 6101 603-165 E-Mail: [email protected] Or visit us via our website at Follow @stadaGroup on LinkedIn STADA information for capital market participants STADA Arzneimittel AG - Investor & Creditor Relations Stadastrasse 2-18, 61118 Bad Vilbel – Germany Phone: +49 (0) 6101 603-4689 Fax: +49 (0) 6101 603-215 E-mail: [email protected] Or visit us via our website at Bio-Thera Contacts Bio-Thera Solutions, Ltd Bert E. Thomas IV +1.410.627.1734 [email protected] SOURCE Bio-Thera Solutions, Ltd 21% more press release views with Request a Demo

November 25, 2025 — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Commission (EC) has approved AVT03 as a biosimilar to Prolia® and Xgeva® (denosumab). The European denosumab market is currently valued at approximately US$1.2 billion across all indications, based on originator sales in the last 12 months including the second quarter of 2025[1]. Denosumab is widely used to manage osteoporosis and to prevent skeletal related events in patients with certain cancers. A biosimilar option can help broaden access to these established treatments in Europe. AVT03 is approved in two presentations: as a biosimilar to Prolia® 60 mg/mL single use pre-filled syringe for the treatment of osteoporosis and bone loss; and as a biosimilar to Xgeva® 70 mg/mL single use vial for the prevention of skeletal related events in adults with advanced malignancies involving bone. “We welcome the European Commission’s approval of AVT03, which demonstrates the continued strength of our end-to-end platform and our ability to deliver high quality biosimilars at scale. This milestone reflects not only the dedication and expertise of our teams, but also the strong partnerships we have built to bring affordable medicines to patients across Europe. Working together, we can help broaden access to essential osteoporosis and oncology supportive care treatments and strengthen the resilience of supply in key markets,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech. The EC decision represents continued progress across Alvotech’s biosimilar portfolio and underscores the company’s role as a longer term partner to health systems across Europe. In Europe, disabilities due to osteoporosis are greater than those caused by common cancers (with the exception of lung cancer) and comparable to those caused by chronic noncommunicable diseases, such as rheumatoid arthritis, asthma and high blood pressure. Fragility fractures represent a significant economic burden, with incident and prior fragility fractures estimated at €57 billion in 2019[2]. Biosimilars play an important role in supporting sustainable healthcare budgets across Europe by offering cost-effective treatment options. In Europe, AVT03 will be commercialised in partnerships with STADA and Dr. Reddy’s, where each partner holds semi-exclusive rights in the EEA, Switzerland and the UK. STADA will market AVT03 as Kefdensis®, biosimilar to Prolia® and as Zvogra®, biosimilar to Xgeva®. Dr. Reddy’s will market AVT03 as Acvybra®, biosimilar to Prolia® and as Xbonzy®, biosimilar to Xgeva®. The European Commission’s approval of AVT03 as a biosimilar to Prolia and Xgeva was based on a totality of evidence that included comparative analytical, pharmacokinetic and pharmacodynamic data, and data from a confirmatory clinical study. The clinical data package included the PK similarity study AVT03-GL-P01[3] in healthy adult males (ClinicalTrials.gov identifier NCT05126784) and the comparative efficacy study AVT03-GL-C01[4] in post menopausal women with osteoporosis (ClinicalTrials.gov identifier NCT05395091) with Prolia used as the reference product in both clinical studies. The results of the clinical studies demonstrate equivalent pharmacokinetics and efficacy, and comparable safety and immunogenicity to the reference product and were reported in peer reviewed publications[3,4] . Analytical similarity studies also compared AVT03 with both Prolia and Xgeva. AVT03 is a human monoclonal antibody and a biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use vial), that has been approved for marketing in the EEA and Japan. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction[5]. Prolia® and Xgeva® are registered trademarks of Amgen Inc. Kefdensis® and Zvogra® are registered trademarks of STADA Arzneimittel. Acvybra® and Xbonzy® are registered trademarks of Dr. Reddy’s Laboratories SA. References [1] IQVIA [2] Osteoporosis in Europe: a compendium of country-specific reports | Archives of Osteoporosis [3] Expert Opinion on Investigational Drugs Vol. 34, 2025 – Issue 6 [4] Expert Opinion on Biological Therapy, Vol. 25, 2025 – Issue 8 [5] Prolia product information, EMA Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab), are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has established a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. The content above comes from the network. if any infringement, please contact us to modify.