The Food and Drug Administration (FDA) has approved Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF), a biosimilar to Humira (adalimumab).
Similar to the reference product, Hyrimoz HCF is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.
The approval of the new citrate-free, high-concentration formulation (100mg/mL) was based on data from a phase 1 pharmacokinetics bridging study comparing adalimumab-adaz 50mg/mL to 100mg/mL. Findings showed that the study met all of the primary objectives confirming similar safety, immunogenicity, and pharmacokinetics of Hyrimoz 50mg/mL and the high-concentration formulation.
“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” said Keren Haruvi, President, Sandoz Inc., Head of North America.
The citrate-free, HCF biosimilar product is expected to be available on July 1, 2023.
- Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation. News release. Sandoz. Accessed March 21, 2023. https://www.globenewswire.com/news-release/2023/03/21/2631529/0/en/Sandoz-receives-US-FDA-approval-for-biosimilar-Hyrimoz-adalimumab-adaz-high-concentration-formulation.html.
- Package insert. Sandoz; 2023. Accessed March 21, 2023. https://www.us.sandoz.com/sites/www.us.sandoz.com/files/Hyrimoz_Highlights_Prescribing_Information.pdf.