EMA accepts Sandoz’s application for proposed biosimilar adalimumab’s high concentration formulation

According to the company’s press statement, as part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL2 and Hyrimoz HCF.

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On Tuesday, a split panel with two of the same judges reversed the decision.

Sandoz on Friday announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz® (adalimumab) for regulatory review. The application includes all indications covered by the reference medicine, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and uveitis, the company claimed.

Due to this acceptance, the Hyrimoz (100 mg/mL) citrate-free HCF would offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg dosing. Moreover, Hyrimoz HCF will have the same auto injector as Hyrimoz 50 mg/mL, aiming for an enhanced yet familiar patient experience.

“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 fueling pharmaceutical innovation,” said Florian Bieber, Global Head Biopharmaceuticals Development, Sandoz.

According to the company’s press statement, as part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL2 and Hyrimoz HCF. Meanwhile, this study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the Hyrimoz 50 mg/mL and Hyrimoz HCF.

“This potential approval of Hyrimoz HCF builds on the already approved and well-established Sandoz biosimilar portfolio in immunology, including Erelzi® (biosimilar etanercept), Zessly® (biosimilar infliximab) and Rixathon® (biosimilar rituximab, including rheumatoid arthritis indication). Sandoz’ Hyrimoz 50 mg/mL was first approved by the European Commission in July 2018 and launched in several European countries shortly thereafter,” the company stated.

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