Sandoz, Inc.

BASEL, Switzerland I August 12, 2024 I Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved Enzeevu™ (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu™ is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD).[1] In addition, the FDA provisionally determined Enzeevu™ would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products. Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: “nAMD, or wet AMD, continues to be a leading cause of vision impairment in patients over 50 years in North America. This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision. The US approval of Enzeevu™ is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.” Enzeevu™ is a key biosimilar value driver for the company and this approval is a major step in advancing the Sandoz growth strategy by further extending its leading US ophthalmology portfolio. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements. nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients over 50 years in North America.[2] Jeff Todd, J.D., President and CEO of Prevent Blindness, said: “As sight disappears, so may a person’s connection to the world. We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer. At this time, there is no cure for this disease and long-term treatment can be costly. Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable.” The FDA granted approval based on the totality of evidence, including comprehensive analytical and preclinical in vitro study data, as well as clinical data from the Mylight study.[3] This approval follows the acquisition of the Cimerli® (ranibizumab-eqrn) business by Sandoz in the US earlier in 2024. The acquisition, which included field force employees, strengthened the company’s leading ophthalmology portfolio in the US and created a robust platform to support the anticipated launch of Enzeevu™. References [1] Enzeevu™. Prescribing Information. Available at: https://prod.cms.us.sandoz.com/sites/spare37_sandoz_com/files/Media%20Documents/ENZEEVU_PI_2024_2.pdf [Last accessed: August 2024] [2] American Academy of Ophthalmology®. Age-related macular degeneration (AMD). Available at: https://www.aao.org/eye-health/diseases/amd-macular-degeneration [Last accessed: August 2024] [3] Arnaldo B, et al. Efficacy and safety of the proposed biosimilar aflibercept, SDZ-AFL, in patients with neovascular age-related macular degeneration: 52-week results from the Phase 3 Mylight study. Retina. 2024. About Enzeevu™ (aflibercept-abzv) The active ingredient in Enzeevu™ is aflibercept. Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. In patients with neovascular age-related macular degeneration (nAMD), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression. About Mylight study The Mylight study (NCT04864834) was an international, multicenter, randomized, double-masked, 2-arm parallel study in 485 patients with neovascular age-related macular degeneration (nAMD), with a total duration of 52 weeks.[3] The Mylight study confirmed equivalent efficacy, as well as comparable safety and immunogenicity for Sandoz biosimilar aflibercept and reference medicine Eylea®* (aflibercept) as per Eylea®* approved treatment regimen in patients with nAMD.[3] *Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc. INDICATIONS Enzeevu™ is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infection Active intraocular inflammation Hypersensitivity WARNINGS AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. This is not the complete list of all the safety information for Enzeevu™. Please see full Prescription Info for Enzeevu™ . 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 100 nationalities work together to ensure 800 million patient treatments are provided 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 world’s first biosimilar in 2006. In 2023, Sandoz recorded sales of USD 9.6 billion. SOURCE: Sandoz

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules Sandoz launches biosimilar Pyzchiva® (ustekinumab) across Europe, to treat chronic inflammatory diseases Launch across Europe, starting today, strengthens well-established Sandoz immunology portfolio in Europe, leveraging existing footprint Pyzchiva® first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130mg vial initiation dose for Crohn’s disease Pyzchiva® to treat adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis July 25, 2024 – Sandoz, the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab) across Europe, starting today. Pyzchiva®, developed and registered by Samsung Bioepis, is the first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including the 130mg vial initiation dose for Crohn’s disease. The launch strengthens our well-established immunology portfolio in Europe and leverages our existing footprint, with five biosimilars now marketed in this therapeutic area. Pyzchiva® is a key biosimilar driver, adding value and contributing to the company’s mid-term growth strategy. Rebecca Guntern, President Europe, Sandoz, said: “Timely and expanded access to safe, effective and affordable medicines can improve quality of life for millions of people living with chronic inflammatory diseases. Our goal is to make potentially life-changing medicines accessible to patients across Europe. Pyzchiva® is one of the first ustekinumab biosimilars in Europe, which marks a significant milestone on that road.” Pyzchiva® is approved for treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg. Europe has the highest prevalence of psoriasis worldwide, affecting an estimated 6.4 million people and significantly impacting patients’ quality of life.1,2 Plaque psoriasis is the most common form of psoriasis, affecting 85% to 90% of patients with psoriasis.3 Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva® in the US, Canada, the European Economic Area, Switzerland, and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing, and supply. Pyzchiva® (ustekinumab) has been developed as a biosimilar with equivalent efficacy and comparable safety to the reference medicine Stelara®**, a human monoclonal antibody against interleukin (IL)-12/23. Pyzchiva® is approved for treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg. Pyzchiva® is available as a 130 mg concentrate in a vial for solution for infusion, additionally, a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe. References International Federation of Psoriasis Associations (IFPA). Speaking up for psoriatic disease in Europe. Available at: https://cms.ifpa-pso.com/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf [Last accessed July 2024]. Frede N, et al. Psoriasis and Psoriatic Arthritis Have a Major Impact on Quality of Life and Depressive Symptoms: A Cross-Sectional Study of 300 Patients. Rheumatology and Therapy. 2023;10: 1655–1668. doi: 10.1007/s40744-023-00602-9. Palfreeman AC, McNamee KE, McCann FE. New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast. Drug Des Devel Ther. 2013;7:201-10. 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. In 2023, Sandoz recorded sales of USD 9.6 billion. Global Media Relations contactsInvestor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comJoerg E. Allgaeuer The content above comes from the network. if any infringement, please contact us to modify.

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_