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Positive topline results demonstrate clinical similarity between AVT03 and the reference biologic, Prolia® (denosumab) Two additional studies comparing the pharmacokinetics, safety, and tolerability of AVT03 to Prolia and Xgeva, respectively, have also met their primary endpoint Alvotech expects to file marketing applications for AVT03 later this year for major global markets July 02, 2024 -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab). The study met its primary endpoints. The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK) in postmenopausal women with osteoporosis. The results will be used to support additional indications for AVT03 as a proposed biosimilar to Xgeva, based on extrapolation. “We are pleased with these results, demonstrating clinical similarity between AVT03 and the reference biologic. In addition, we have now obtained positive topline results from two PK studies, that show equivalent PK, safety, and tolerability of AVT03 compared to Prolia and Xgeva, respectively. These clinical milestones underline the capabilities of our dedicated biosimilar platform and continued diversification of our portfolio. We expect to file marketing applications for AVT03 for major global markets later this year,” said Joseph McClellan, Chief Scientific Officer of Alvotech. Prolia (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture. Xgeva (denosumab), which is the same biologic in a different presentation, is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumor in bone. The confirmatory patient study, AVT03-GL-C01, is a randomized, double-blind, parallel design, repeat dose, two arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of AVT03 and Prolia in postmenopausal women with osteoporosis. Approximately 532 participants, postmenopausal women 50 years or older diagnosed with osteoporosis, were randomly assigned between the two arms. Each participant receives three doses of either AVT03 or Prolia, at six-month intervals. The study included a re-randomization in the Prolia arm, with participants receiving a third dose of either AVT03 or Prolia. The primary outcome measures were change from baseline in bone mass density (BMD) and a biomarker for bone resorption. The primary endpoints were measured at 6 and 12 months, but all participants will be followed until an end of study visit after 18 months from the initial dose. The AVT03-GL-P01 study, assessed the PK, safety, and tolerability of AVT03 compared to Prolia in 209 healthy adult participants, and the AVT03-GL-P03 study assessed the PK, safety, and tolerability of AVT03 compared to Xgeva in 208 healthy adult participants. Both studies met their primary endpoints. AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). 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 [1]. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed. [1] https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf 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. Alvotech has launched two biosimilars. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, 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. 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 (US, EU), 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 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.

Sandoz plans to launch the biosimilar products for bone-related ailments from November 2025. Credit: Tong_stocker / Shutterstock.com. The European Commission (EC) has granted marketing authorisation for Sandoz ’s biosimilars Wyost (denosumab) and Jubbonti (denosumab) for bone-related ailments. Wyost and Jubbonti are the first biosimilars of reference medicines Xgeva and Prolia to receive approval in Europe. Wyost is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. It is also intended for the treatment of adult and skeletally mature adolescent patients with giant cell bone tumours. Sandoz’s Jubbonti can be used for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, among other bone loss conditions. The company plans to launch these products from November 2025. See Also: ASCO 2024: Verastem’s combo therapy for pancreatic cancer hits early trial success FDA advisory committee reviews Novo Nordisk insulin icodec for T1D Wyost and Jubbonti contain denosumab, a human monoclonal antibody that hinders the RANKL/RANK interaction. This mechanism is crucial as it prevents the formation and activity of osteoclasts, cells responsible for bone resorption, thus aiding in the maintenance of bone integrity. The EC’s authorisation for Wyost and Jubbonti was based on comprehensive development programmes that demonstrated biosimilarity to their reference medicines. The biosimilars have been developed to match the original products in terms of dosage form, route of administration, dosing regimen and presentation. Sandoz chief scientific officer Claire D’Abreu-Hayling stated: “Primary and secondary bone loss, as well as cancer-related bone events, represent an immense disease burden for patients, the economy and society as a whole. “The approval of the first European denosumab biosimilars is a crucial recognition of the need for increased access to these potentially life-changing medicines and demonstrates our continued commitment to delivering more sustainable treatment options for patients, in Europe and beyond.” In March 2024, the US Food and Drug Administration approved Sandoz’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) as denosumab biosimilars .

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Wyost® (denosumab) and Jubbonti® (denosumab) approved by EC for all indications of denosumab reference medicines Xgeva® and Prolia® EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of safety, efficacy and quality Approved for treatment of cancer-related bone disease and osteoporosis respectively Basel, May 22, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the European Commission (EC) has granted marketing authorization for Wyost®1 (denosumab) and Jubbonti®2 (denosumab), the first and only biosimilar versions of reference medicines Xgeva®*3 and Prolia®*4 in Europe. Wyost® is approved for the treatment of cancer-related bone disease.1 Jubbonti® is approved to treat osteoporosis.2 These are key biosimilar value drivers for the company over the mid-term and their approval is a major step in advancing the Sandoz growth strategy. We expect to launch from November 2025 onwards. Claire D'Abreu-Hayling, Sandoz Chief Scientific Officer, said: "Primary and secondary bone loss, as well as cancer-related bone events, represent an immense disease burden for patients, the economy and society as a whole. The approval of the first European denosumab biosimilars is a crucial recognition of the need for increased access to these potentially life-changing medicines and demonstrates our continued commitment to delivering more sustainable treatment options for patients, in Europe and beyond." Close to one quarter (4.2 million) of all newly reported cancer cases globally occur in Europe and cancer is ranked as a leading cause of premature death among those 30-69 years of age in most European countries.5 Nearly all types of cancer can spread to the bone and cause pain and fractures, though cancers that often metastasize in bones include breast and prostate.6 In Europe, 32 million people over 50 years were estimated to live with osteoporosis in 2019 with the number of fractures per year set to increase by almost 25% until 2034.7 Despite wide availability of treatments only a minority of patients at high risk currently receive treatment, even after their first fracture.8 About Wyost® and Jubbonti® Wyost® and Jubbonti® have been developed to match the reference medicines. Both medicines contain the same active ingredient (denosumab), a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone. The EC approvals are based on robust development programs. Wyost and Jubbonti have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines. Wyost is indicated in Europe to prevent skeletal related events (SREs; pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone and to treat adults and skeletally mature adolescents with a giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity1. Jubbonti is indicated in Europe to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture2. *Prolia® and Xgeva® are registered trademarks of Amgen Inc. Disclaimer This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. References European Medicines Agency (EMA). Wyost® (Denosumab): Prescribing Information. Available from: [Last accessed: May 2024] European Medicines Agency (EMA). Jubbonti ® (Denosumab): Prescribing Information. Available from: [Last accessed: May 2024] European Medicines Agency (EMA). Xgeva® (Denosumab): Prescribing Information. Available from: [Last accessed: May 2024]. European Medicines Agency (EMA). Prolia® (Denosumab): Prescribing Information. Available from: [Last accessed: May 2024]. The Cancer Atlas. The Burden of Cancer. Available from: [Last accessed: May 2024] American Cancer Society. Bone Metastases. Available from: [Last accessed: March 2024] International Osteoporosis Foundation. SCOPE ’21. ScoreCard for OsteoPorosis in Europe. Available from: [Last accessed: May 2024] International Osteoporosis Foundation. Facts and Statistics. Available from: [Last accessed: May 2024] About Sandoz Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of more than 100 nationalities work together to ensure 800 million patient treatments are provided annually by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Joerg E. Allgaeuer +49 171 838 4838 Karen M. King +1 609 722 0982 Chris Lewis +49 174 244 9501 Laurent de Weck +41 79 795 7364 Attachment FINAL_Media Release denosumab EC approval_