Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF) – Novartis

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Basel, July 21, 2022 – Sandoz, a global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz® (adalimumab-adaz). The application includes the indications of the reference medicine Humira® (adalimumab)* not protected by orphan exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
“Biosimilars play a crucial role in generating billions of dollars of savings for patients and the US healthcare system every year, while improving healthcare sustainability,” said Keren Haruvi, President, Sandoz Inc., Head of North America. “Should the Hyrimoz HCF be approved, we believe this important biosimilar medicine would help expand access to more patients with serious inflammatory diseases, including those who currently may not have access to it.”
Hyrimoz 50 mg/mL was approved by the US FDA in 2018. In accordance with recommendations from the US FDA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF. This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz HCF.
Recently, the European Medicines Agency also accepted the application for Sandoz proposed Hyrimoz HCF.
The potential US FDA approval of the HCF for Hyrimoz builds on the already approved and well-established Sandoz global biosimilar portfolio in immunology. Sandoz has more than 65 million days of patient experience with Hyrimoz 50 mg/mL worldwide and if approved, Hyrimoz 100 mg/mL citrate-free HCF would represent the first launch of a Sandoz biosimilar in the US market in this specific disease space.
Sandoz is committed to helping millions of patients access biologic medicines sustainably in areas including oncology and immunology. With a strong global 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 .1,2 In 2015, the US FDA and European Medicines Agency approved Humira® HCF, which contains adalimumab at a concentration of 100 mg/mL.3,4
Important Safety Information
INDICATIONS:
HYRIMOZ is a tumor necrosis factor (TNF)-blocker indicated for:
IMPORTANT SAFETY INFORMATION:
WARNINGS AND PRECAUTIONS


Serious Infections
Malignancies
Hypersensitivity Reactions
Hepatitis B Virus Reactivation
Neurologic Reactions
Hematological Reactions
Heart Failure
Autoimmunity
Immunizations
ADVERSE REACTIONS
The most common adverse reactions (incidence > 10 %): infections (e.g., upper respiratory, sinusitis), injection site reactions, headache and rash.
Please see full Prescribing Information for Hyrimoz.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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.
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 all major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.
Sandoz on social media:
LinkedIn: https://www.linkedin.com/company/sandoz
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CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/
References
*Humira is a registered trademark of AbbVie Biotechnology Ltd
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