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

  • Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study
  • Proposed Hyrimoz® HCF would help expand access to medicine for patients with chronic immune-mediated inflammatory diseases
  • Sandoz is committed to supporting healthcare professionals to advance patient care and improve access to medicines sustainably and affordably

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

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.

Source link:https://www.novartis.com/

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