Infliximab-QBTX

Biosimilar Hyrimoz® (adalimumab) citrate-free high-concentration formulation (HCF) indicated for all conditions of reference medicine Humira®* Hyrimoz® HCF to launch progressively across Europe Hyrimoz® HCF strengthens well-established Sandoz biosimilar immunology portfolio in Europe Basel, November 21, 2023 – Sandoz, the global leader in generic and biosimilar medicines, today announces the launch of Hyrimoz® (adalimumab) citrate-free high concentration formulation (HCF; 100 mg/mL) in Europe. The medicine will become available to patients progressively across European markets, starting today. Hyrimoz® HCF, like the currently available 50mg/mL version of Hyrimoz®, is indicated for all conditions covered by the reference medicine*: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.1 Rebecca Guntern, President Europe Sandoz said: “People living with chronic inflammatory conditions can experience debilitating effects on daily life. The launch of Hyrimoz® HCF in Europe is a key milestone in offering an additional treatment option to those that need it and showcases our unwavering commitment to expanding access to high-quality medicines.” Hyrimoz® citrate-free HCF is an updated formulation (100 mg/mL) to the currently available Hyrimoz® 50 mg/mL and offers a 50 percent reduction in injection volume, thereby potentially decreasing the number of injections required for patients who need 80 mg/mL or higher dosing. The HCF formulation is administered with the familiar Hyrimoz® SensoReady® pen, aiming for an enhanced yet familiar patient experience. The launch of Hyrimoz ® HCF strengthens the Sandoz biosimilar portfolio in immunology, including Erelzi® (biosimilar etanercept), Zessly® (biosimilar infliximab) and Rixathon® (biosimilar rituximab, including rheumatoid arthritis indication). Hyrimoz® citrate-free HCF (adalimumab-adaz) launched in the US in July 2023. Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation. About adalimumab Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). The adalimumab reference medicine (Humira®*) was first approved with an adalimumab concentration of 50 mg/mL.1 In 2015, the EMA and US FDA approved Humira® HCF, which contains adalimumab at a concentration of 100 mg/mL. 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 EMA. Humira® EPAR Product Information. Available from: . [Accessed October 2023] *Humira® is a registered trademark of AbbVie Biotechnology Ltd # # # 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. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 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 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion. 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 Media Release Hyrimoz Launch Version FINAL

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics studyAdalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patientsSubmission builds on Sandoz’ well established biosimilar immunology portfolio in Europe Basel, June 17, 2022 — Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz® (adalimumab) for regulatory review. The application includes all indications covered by the reference medicine*, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis1. Upon approval, the Hyrimoz (100 mg/mL) citrate-free HCF would offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg dosing. Hyrimoz HCF will have the same auto injector as Hyrimoz 50 mg/mL, aiming for an enhanced yet familiar patient experience. “At Sandoz, we are constantly looking for ways to meet the changing needs of patients and health care providers,” said Florian Bieber, Global Head Biopharmaceuticals Development, Sandoz. “By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical innovation.” As part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL2 and Hyrimoz HCF. This study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the Hyrimoz 50 mg/mL and Hyrimoz HCF. This potential approval of Hyrimoz HCF builds on the already approved and well-established Sandoz biosimilar portfolio in immunology, including Erelzi® (biosimilar etanercept), Zessly® (biosimilar infliximab) and Rixathon® (biosimilar rituximab, including rheumatoid arthritis indication). Sandoz’ Hyrimoz 50 mg/mL was first approved by the European Commission in July 2018 and launched in several European countries shortly thereafter. Sandoz is committed to helping millions of patients access biologic medicines sustainably in areas including oncology and immunology. With a strong portfolio of eight marketed biosimilars and a further 15+ in various stages of development, Sandoz has an unparalleled heritage and extensive expertise in the development, manufacturing and delivery of biosimilar medicines to patients and the healthcare community worldwide. About adalimumab Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). The adalimumab reference medicine (Humira®*) was first approved with an adalimumab concentration of 50 mg/mL.2,3 In 2015, the EMA and US FDA approved Humira® HCF, which contains adalimumab at a concentration of 100 mg/mL.4,5 DisclaimerThis 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 forwardlooking statements contained in this press release as a result of new information, future events or otherwise. About Sandoz Sandoz, 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 2021 sales of USD 9.6 billion. Sandoz on social media: LinkedIn: https://www.linkedin.com/company/sandoz Twitter: 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/ References1. EMA. Humira® EPAR Product Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/humira. [Accessed June 2022]2. EMA. Hyrimoz® EPAR Product Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz. [Accessed June 2022]*Humira® is a registered trademark of AbbVie Biotechnology Ltd # # # Novartis and Sandoz Global Communications Chris Lewis Sandoz Global Communications +49 174 244 9501 (mobile) chris.lewis@sandoz.com Richard Jarvis Novartis Communications and Engagement +44 7966 118 652 richard.jarvis@novartis.com Novartis Media RelationsE-mail : media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com Central North America Samir Shah Thomas Hungerbuehler Isabella Zinck +41 61 324 7944+41 61 324 8425+41 61 324 7188Sloan Simpson +1 862 778 5052