Sandoz gets green light from US FDA for high strength Humira biosimilar
The US Food and Drug Administration (FDA) has approved a citrate-free high-concentration formulation (HCF) of Sandoz’s biosimilar, Hyrimoz (adalimumab-adaz).
US patients can benefit from reduced injection volume with this authorization, said the Novartis subsidiary.
“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.
The FDA approval was based on a Phase I pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL (HCF). The company said the study met all of the primary objectives, demonstrating comparable PK, and showing similar safety and immunogenicity of the adalimumab 50 mg/mL and adalimumab HCF.
The adalimumab citrate-free HCF (100 mg/mL) biosimilar is approved to treat seven indications covered by the reference medicine, Humira, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The reference drug
Adalimumab is a human immunoglobulin G1 monoclonal antibody targeting tumor necrosis factor alpha (TNF-a).
Humira was first approved with an adalimumab concentration of 50 mg/ml. In 2015, the EU and US regulatory agencies approved Humira HCF, which contains adalimumab at a concentration of 100 mg/ml.
The US regulator authorized Sandoz's 50 mg/mL version in 2018. However, the drug will not be available to US patients until the end of September this year due to the outcome of the patent infringement litigation settled between AbbVie and Sandoz.
In January, Sandoz announced that it had received a positive opinion for marketing authorization for Hyrimoz citrate-free HCF by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).