Sandoz launches Hyrimoz® (adalimumab) high-concentration formulation in Europe, aiming to improve patient care

2023-11-21

上市批准生物类似药专利到期免疫疗法

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