Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) biosimilar offers US patients reduced injection volume in citrate-free formulation As one of the only adalimumab HCF biosimilars approved in the US, Hyrimoz HCF expands access for millions of people with serious inflammatory diseases Launch builds upon SandozSandoz 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 SandozSandoz 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 SandozSandoz 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.
SELECT IMPORTANT SAFETY INFORMATION
See full prescribing information for complete boxed warning.
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. 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. 2. Hyrimoz. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl.pdf 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 2022 sales of USD 9.2 billion. LinkedIn: https://www.linkedin.com/company/sandoz
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