Sandoz’s application for proposed high-strength biosimilar adalimumab formulation is accepted by EMA

  • Submission supported by comprehensive analytical and clinical data from a new Phase I pharmacokinetic bridging study

  • High-strength 100 mg/mL formulation of adalimumab aims to provide an enhanced yet familiar patient experience

  • Submission builds on Sandoz’s well-established biosimilar immunology portfolio in Europe

Basel, June 17, 2022 — Sandoz, a global leader in generic medicines and biosimilars, today announced that the European Medicines Agency (EMA) has accepted the application for a 100 mg/mL high-strength (HCF) formulation 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.

Once approved, Hyrimoz citrate-free HCF (100 mg/mL) would offer reduced injection volume and potentially decrease the number of injections needed for patients who require an 80 mg dose. 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 healthcare providers,” said Florian Bieber, Global Head of Biopharmaceutical Development at Sandoz. “By committing to bringing biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are addressing a critical need by expanding access to important medicines and fueling pharmaceutical innovation.

As part of the complete EMA submission dossier, Sandoz conducted a Phase I pharmacokinetic (PK) transition study comparing Hyrimoz 50 mg/mL2 and Hyrimoz HCF. This study achieved all of its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between Hyrimoz 50 mg/mL and Hyrimoz HCF.

This potential Hyrimoz HCF approval builds on Sandoz’s already approved and well-established portfolio of biosimilars 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 gain sustainable access to biologic medicines in areas such as oncology and immunology. With a strong portfolio of eight marketed biosimilars and over 15 more in various stages of development, Sandoz has an unrivaled heritage and extensive expertise in the development, manufacturing and delivery of biosimilar medicines to patients and the healthcare community. in the whole world.

About adalimumab
Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). The reference drug adalimumab (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

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”, “may”, “will”, “plans”, ” “may”, “could”, “should”, “expect”, “anticipate”, “expect”, “believe”, “commit”, “investigate”, “pipeline”, “initiate” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling of the investigational or approved products described in this press release, or regarding potential future revenues from such products. place undue reliance on these statements. These forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to important known and unknown risks and uncertainties. or more of these risks or uncertainties materialize, or if underlying assumptions prove incorrect, actual results could differ 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 indication or labeling in any particular market or time. Nor can there be any guarantee that, if approved, these generic or biosimilar products will be approved for all indications included in the label of the reference product. There is also no guarantee that these products will be commercially successful in the future. In particular, our expectations regarding these products could be affected by, among other things, uncertainties inherent in research and development, including the results of clinical trials and further analysis of existing clinical data; regulatory actions or delays or government regulation generally; particular prescribing preferences of physicians and patients; competition generally, including the potential approval of additional generic or biosimilar versions of these products; global trends toward health care cost containment, including pressures from governments, payers and the general public on pricing and reimbursement and demands for increased price transparency; the results of litigation, including intellectual property litigation or other legal efforts to prevent or limit the sale of its products by Sandoz; general political, economic and business conditions, including the effects and efforts to mitigate pandemic diseases such as COVID-19; security, quality, data integrity or manufacturing issues; potential or actual breaches of data security and data privacy, or disruptions to our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F filed with the Securities and Exchange United States Commission. Novartis is providing the information in this press release as of this date and undertakes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz, a division of Novartis, is a global leader in generic medicines and biosimilars. Our goal is to create pioneering access for patients by developing and commercializing innovative and 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, spanning key therapeutic areas, accounted for $9.6 billion in sales in 2021.

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1.EMA. Humira® EPAR product information. Available at: [Accessed June 2022]
2.EMA. Hyrimoz® EPAR product information. Available at: [Accessed June 2022]

*Humira® is a registered trademark of AbbVie Biotechnology Ltd

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