Vaccination

Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) biosimilar offers US patients reduced injection volume in citrate-free formulationAs one of the only adalimumab HCF biosimilars approved in the US, Hyrimoz HCF expands access for millions of people with serious inflammatory diseasesLaunch builds upon Sandoz global biosimilars legacy, with Hyrimoz 50 mg/mL having nearly 120 million days of patient experience across 41 countries1 Basel, July 1, 2023 – Sandoz, a global leader in generic pharmaceuticals and biosimilars, today announced that the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab-adaz) injection will be available in the United States starting July 1. Hyrimoz HCF (100 mg/mL) is approved to treat all indications no longer covered by the regulatory exclusivity for the reference medicine, Humira®* (adalimumab), as of July 1, 2023, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.2 Please see detailed indications at the end of this announcement. “This is an important moment for Sandoz and for the millions of patients living with chronic inflammatory diseases in the US. With this launch, we are entering the US immunology market and continuing to fulfill our commitment to expand access to important medicines for patients,” said Keren Haruvi, President North America, Sandoz Inc. “Sandoz has a long history of developing and marketing biosimilars that generate healthcare savings and enhance competition that drives innovation in the market. We are pleased to continue this legacy in the US with Hyrimoz, which offers another treatment option for those who need adalimumab but might have previously been unable to access or afford this critical medicine.” Hyrimoz HCF offers a 50% reduction in injection volume compared to the 50 mg/mL concentration and can decrease the number of injections required for people who need at least 80 mg/0.8 mL dosing. The HCF formulation is citrate free and uses the same auto-injector as Hyrimoz 50 mg/mL, the Sensoready® pen, which is designed with patients in mind. The prefilled Sensoready pen is an ergonomic device with a triangular shape, buttonless injection for self-administration and a 360° viewing window for visual feedback. Sandoz has established Sandoz One Source for Hyrimoz, a robust patient support program that provides educational, reimbursement and affordability support. To learn more about Sandoz One Source and Hyrimoz, visit Hyrimoz.com. Product photos available upon request. About Hyrimoz® (adalimumab-adaz)Adalimumab, the active ingredient in Hyrimoz, is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions — including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis — causing inflammation and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz targets and blocks the protein that contributes to disease symptoms.2 INDICATIONS HYRIMOZ® (adalimumab-adaz) is a tumor necrosis factor (TNF)-blocker indicated for Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. Crohn’s Disease (CD): treatment of moderately to severely active CD in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC): treatment of moderately to severely active UC in adult patients. Limitations of Use: Effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic Ps who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HYRIMOZ should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa (HS): treatment of moderate to severe HS in adult patients. SELECT IMPORTANT SAFETY INFORMATION WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS: Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue HYRIMOZ if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting HYRIMOZ. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS: Serious infections: Do not start HYRIMOZ during an active infection. If an infection develops, monitor carefully, and stop HYRIMOZ if infection becomes serious. Invasive fungal infections: For patients who develop a systemic illness on HYRIMOZ, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls. Anaphylaxis or serious hypersensitivity reactions may occur. Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HYRIMOZ and begin anti-viral therapy. Demyelinating disease: Exacerbation or new onset, may occur. Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping HYRIMOZ. Heart failure: Worsening or new onset, may occur. Lupus-like syndrome: Stop HYRIMOZ if syndrome develops. ADVERSE REACTIONS: Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. DRUG INTERACTIONS: Abatacept: Increased risk of serious infection. Anakinra: Increased risk of serious infection. Live vaccines: Avoid use with HYRIMOZ. This is not the complete list of all the safety information for HYRIMOZ. Please click to see the full Prescribing Information for HYRIMOZ, including Boxed Warnings and Medication Guide. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. References1. Data on file (PSUR) 2. Hyrimoz. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl.pdf *Humira is a registered trademark of AbbVie Biotechnology Ltd # # # About SandozSandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2022 sales of USD 9.2 billion. Sandoz on social media:LinkedIn: https://www.linkedin.com/company/sandozTwitter: https://twitter.com/sandoz_globalFacebook: https://www.facebook.com/sandozglobal/Instagram: https://www.instagram.com/sandozglobal CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/ # # # Sandoz Global Communications Central North America Joerg Allgaeuer +49 171 8384838joerg.allgaeuer@sandoz.com Vicki Crafton +1 201.213.6338 (mobile)vicki.crafton@sandoz.com Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Richard Jarvis +41 79 584 2326 Julie Masow +1 862 579 8456 SwitzerlandSatoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Samir Shah +41 61 324 7944 Sloan Simpson +1 862 345 4440 Nicole Zinsli-Somm +41 61 324 3809 Parag Mahanti +1 973 876 4912 Isabella Zinck +41 61 324 7188

BRUSSELS, Belgium I June 07, 2023 I UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorisation for BIMZELX ® (bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. These approvals in the European Union (EU) represent the first marketing authorizations for bimekizumab in PsA and axSpA worldwide, and the second and third indications for bimekizumab in the EU, following its approval for the treatment of moderate to severe plaque psoriasis in August 2021. 1 “The European Commission’s parallel approval of bimekizumab in PsA and axSpA builds on the momentum created since its first approval in moderate to severe plaque psoriasis and marks an exciting milestone offering healthcare professionals and patients the first IL-17A and IL-17F inhibitor for treatment of these diseases,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “The extended approval for bimekizumab in the European Union reflects our commitment to address unmet patient needs, improve patient outcomes and raise standards of care.” In PsA, bimekizumab is approved alone or in combination with methotrexate for the treatment of adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). 1 In axSpA, bimekizumab is approved for the treatment of adults with active nr-axSpA with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs, and for the treatment of adults with active AS who have responded inadequately or are intolerant to conventional therapy. 1 Bimekizumab in PsA: Highlights from BE OPTIMAL and BE COMPLETE The EC approval in PsA is based on results from the Phase 3 BE OPTIMAL and BE COMPLETE studies. 1,2,3 In the two studies, bimekizumab met the primary endpoint of ACR50 response at Week 16 vs. placebo, and all ranked secondary endpoints. 1,2,3 Consistent results were seen across both biologic-naïve and TNF-inhibitor inadequate responder (TNFi-IR) populations. 1 2,3 Clinical responses achieved at Week 16 were sustained up to Week 52 in BE OPTIMAL as assessed by ACR50, PASI90, PASI100 and Minimal Disease Activity (MDA). 1 “The approval of bimekizumab in psoriatic arthritis provides rheumatologists and dermatologists in the European Union with a new treatment option. Data from the Phase 3 clinical studies demonstrated the consistently high thresholds of disease control achieved with bimekizumab vs. placebo in patients with psoriatic arthritis who were biologic naïve or TNF inhibitor-inadequate responders,” said Professor Iain McInnes, University of Glasgow, College of Medical, Veterinary and Life Sciences, Glasgow, Scotland. In BE OPTIMAL, the most frequent treatment-emergent adverse events (TEAEs; 3 percent or more) for patients on bimekizumab up to Week 16 were nasopharyngitis, upper respiratory tract infection, headache, diarrhoea, oral candidiasis, pharyngitis and hypertension. 2 In BE COMPLETE, the most frequent TEAEs (2 percent or more) for patients on bimekizumab up to Week 16 were nasopharyngitis, oral candidiasis and upper respiratory tract infection. 3 Bimekizumab in axSpA: Highlights from BE MOBILE 1 and BE MOBILE 2 The EC approval in axSpA is based on results from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies. 1,4 In the two studies, bimekizumab met the primary endpoint of Assessment of SpondyloArthritis international Society (ASAS) 40 response at Week 16 vs. placebo, and all ranked secondary endpoints. 4 ASAS40 responses were consistent across TNFi-naïve and TNFi-inadequate responder patients. 4 Clinical responses achieved at Week 16 were sustained in both nr-axSpA and AS patient populations up to Week 52 as assessed by ASAS40 and other endpoints. 1,5 In addition, in pooled data from BE MOBILE 1 and BE MOBILE 2, at Week 16, the proportion of patients developing a uveitis event was lower with bimekizumab (0.6 per cent) compared to placebo (4.6 percent). The incidence of uveitis remained low with long-term treatment with bimekizumab (1.2/100 patient-years in the pooled Phase 2/3 studies). 1 “Today’s approval of a new treatment option for axial spondyloarthritis is welcome news to the European rheumatology community. In phase 3 clinical studies a greater proportion of patients treated with bimekizumab, compared with placebo, achieved high treatment targets with significant improvement in signs, symptoms and measures of disease activity across the full spectrum of disease, including non-radiographic and radiographic populations,” said Professor Désirée van der Heijde, Professor of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands. The most frequently reported TEAEs (3 percent or more in any bimekizumab group in either trial) up to Week 16 were nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis. 4 Notes to editors: About BE OPTIMAL and BE COMPLETE The safety and efficacy of bimekizumab (160 mg every four weeks) were evaluated in adult patients with active psoriatic arthritis (PsA) in two multicentre, randomized, double-blind, placebo-controlled studies (BE OPTIMAL and BE COMPLETE). 1,2,3 The BE OPTIMAL study evaluated 852 patients not previously exposed to any biologic disease-modifying anti-rheumatic drug (bDMARD-naïve) for the treatment of psoriasis or psoriatic arthritis. 2 The BE COMPLETE study evaluated 400 patients with an inadequate response or intolerance to treatment with one or two tumour necrosis factor alpha inhibitors (TNFi-IR) for either psoriatic arthritis or psoriasis. 3 Detailed findings from the BE OPTIMAL and BE COMPLETE studies are published in The Lancet. 2,3 About BE MOBILE 1 and BE MOBILE 2 The efficacy and safety of bimekizumab (160 mg every four weeks) were evaluated in 586 adult patients with active axial spondyloarthritis (axSpA) in two multicenter, randomized, double-blind, placebo-controlled studies, one in non-radiographic axSpA (nr-axSpA; BE MOBILE 1) and one in ankylosing spondylitis (AS; BE MOBILE 2), also known as radiographic axSpA. 1,4 The BE MOBILE 1 and BE MOBILE 2 studies evaluated 254 and 332 patients, respectively. 4 Detailed findings from the BE MOBILE 1 and BE MOBILE 2 studies are published in the Annals of the Rheumatic Diseases. 4 About bimekizumab Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes. 1,6 The therapeutic indications in the European Union are: BIMZELX ® ▼ (bimekizumab) EU/EEA* Important Safety Information 1 The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3% in plaque psoriasis (PSO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), respectively) and oral candidiasis (7.3%, 2.3%, 3.7% in PSO, PsA and axSpA, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab. Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis). Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB. Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated. Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated. Live vaccines should not be given in patients treated with bimekizumab. Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information. European SmPC date of revision: June 2023. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product- information_en.pdf *EU/EEA means European Union/European Economic Area ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. For further information, contact UCB: About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. References SOURCE: UCB

The European Commission expanded approval of UCB's Bimzelx (bimekizumab) to include the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA), including non-radiographic (nr-axSpA) and ankylosing spondylitis (AS). The company noted that the authorisation marks the first for the dual IL-17A and IL-17F inhibitor in the two indications.Bimzelx was initially cleared in Europe in 2021 for the treatment of moderate-to-severe plaque psoriasis. The product, which is also available in the UK, Canada and Japan, generated sales of €35 million ($38 million) last year, up from €4 million ($4.3 million) in the prior 12-month period.According to UCB, Bimzelx is approved alone or in combination with methotrexate for the treatment of adults with PsA who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Meanwhile, the therapy is indicated for adults with active nr-axSpA who show objective signs of inflammation and who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs. It is also indicated for adults with active AS who have responded inadequately or are intolerant to conventional therapy.Results supporting approval in PsA come from the Phase III BE OPTIMAL and BE COMPLETE studies, in which Bimzelx met the primary endpoint of ACR50 response at week 16 versus placebo. Meanwhile, clearance in axSpA is based on findings from the late-stage BE MOBILE 1 and BE MOBILE 2 trials, with UCB's therapy achieving the primary endpoint of Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16 compared to placebo.US decision pendingUCB is also seeking approval of Bimzelx in the US, but has so far been unsuccessful, with the FDA issuing a complete response letter last year in relation to a filing in moderate-to-severe plaque psoriasis. The agency cited a number of deficiencies at a Belgian manufacturing plant, although the company was quick to resubmit its application, which has a target review date in the second quarter of 2023.However, last month, the FDA published a notice disclosing a Form 483 that had been sent to UCB outlining three issues identified at a follow-up visit to the manufacturing facility. Although Jefferies analyst Brian Balchin suggested that the deficiencies appear "less challenging" than those that resulted in the initial rejection, he said another complete response letter could further delay approval until the second quarter of 2024.For related analysis, read Spotlight On: UCB hoping to avoid painful déjà vu on Bimzelx.