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The approval was based on positive results from the phase I pharmacokinetics bridging study, which showed comparable PK and similar safety and immunogenicity of adalimumab 50 mg/mL and adalimumab high-concentration formulation.
Sandoz announced the US Food and Drug Administration (FDA) approval of a citrate-free high-concentration formulation (HCF) version of its biosimilar adalimumab-adaz (Hyrimoz) (100 mg/mL) injection. Adalimumab-adaz HCF was approved for 7 indications of the reference drug, including psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, plaque psoriasis, juvenile idiopathic arthritis, Crohn’s disease, and ankylosing spondylitis.
“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,” Keren Haruvi, President, Sandoz Inc, Head of North America, said in a statement.
The decision was based on a phase 1 pharmacokinetics (PK) bridging study which compared the FDA-approved adalimumab 50 mg/mL to the HCF citrate-free 100 mg/mL version. All primary objectives were met, emphasizing the PK comparability along with a similar safety profile and immunogenicity of both adalimumab 50 mg/mL and adalimumab HCF.
The HCF biosimilar, which will be launched in Q3 2023, will allow for patients to receive a reduced injection volume in a citrate-free formulation. The drug marks the first Sandoz biosimilar introduced to the US market for these specific conditions.
“Biosimilars are extensively studied, FDA-approved treatments,” Steve Taylor, president and chief executive officer, Arthritis Foundation, stated. “There are millions of patients affected by chronic inflammatory conditions that drastically impact their everyday lives. Given the high burden of disease for these conditions, biosimilars are one potential solution for healthcare providers and patients to consider, to ensure patients can take and stay on their medicines to help manage their disease and health outcomes.”