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Sandoz’s biosimilar medicine application accepted by FDA

If approved, the higher concentration formulation could decrease the number of injections required for patients currently receiving a lower dose of Hyrimoz


The US Food and Drug Administration (FDA) has accepted for review Sandoz’s Supplemental Biologics Licence Application (sBLA) for a high concentration formulation of 100mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab).

The latest application comprises all indications covered by the reference medicine, including Crohn’s disease, plaque psoriasis, ulcerative colitis, rheumatoid arthritis and uveitis.

Hyrimoz was approved by the FDA in 2018, with a concentration of 50mg/mL. Recently, the European Medicines Agency (EMA) also accepted the application for Sandoz’s proposed Hyrimoz HCF.

Keren Haruvi, president, Sandoz, head of North America, said: "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.

“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.”

To support the submission, Sandoz ran a phase 1 pharmacokinetic bridging study that compared the 50mg/mL and Hyrimoz HCF.

According to the findings, the study met all of the primary endpoints, showing comparable pharmacokinetics and similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz HCF.

If approved, the Hyrimoz citrate-free HCF would offer reduced injection volume, potentially decreasing the number of injections required for patients who need an 80mg dosing. Hyrimoz HCF will also have the same auto-injector as Hyrimoz 50mg/mL, which would give patients an improved yet familiar experience.

A human immunoglobulin G1 (IgG1) monoclonal antibody, Hyrimoz acts on tumour necrosis factor-alpha (TNF-a). Sandoz has over 65 million days of patient experience with Hyrimoz 50mg/mL worldwide and if approved, Hyrimoz citrate-free HCF would represent the first launch of a Sandoz biosimilar in the US market in this specific disease space.

Commenting on the recently accepted application by the EMA, Florian Bieber, global head of Biopharmaceuticals Development, Sandoz, said: “At Sandoz, we are constantly looking for ways to meet the changing needs of patients and health care providers.

“By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fuelling pharmaceutical innovation.”

Article by
Emily Kimber

21st July 2022

From: Research, Regulatory



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