The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for a high concentration formulation of 100mg/mL (HCF) of Hyrimoz® (adalimumab-adaz), a biosimilar to Humira (adalimumab).
The application for Hyrimoz HCF, a tumor necrosis factor (TNF) blocker, includes the following indications not protected by orphan exclusivity: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.
The sBLA is supported by data from a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50mg/mL and citrate-free Hyrimoz HCF. Findings showed that the study met all of the primary objectives confirming similar safety, immunogenicity, and pharmacokinetics of Hyrimoz 50mg/mL and Hyrimoz HCF.
In 2018, the FDA approved Hyrimoz 50mg/mL based on data from analytical, preclinical, and clinical research showing that Hyrimoz matched the reference product’s safety, efficacy, and quality.
“Biosimilars play a crucial role in generating billions of dollars of savings for patients and the US healthcare system every year, while improving health care 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.”
Sandoz supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF). News release. Sandoz. Accessed July 21, 2022. https://www.novartis.com/news/media-releases/sandoz-supplemental-biologics-license-application-accepted-us-fda-biosimilar-hyrimoz-adalimumab-adaz-high-concentration-formulation-hcf