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Sandoz’s high concentration Hyrimoz formulation recommended for use in EU

The recommendation includes multiple indications such as rheumatoid arthritis and Crohn’s disease


Sandoz has received a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab).

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

Hyrimoz was originally approved by the European Commission in 2018, with a concentration of 50mg/mL.

If approved, the Hyrimoz 100mg/mL HCF would offer reduced injection volume, potentially decreasing the number required for patients who need 80mg dosing.

The company also outlined that the HCF will have the same auto-injector as Hyrimoz 50mg/mL, which would give patients an ‘enhanced yet familiar experience’, it said.

“For people who live with a chronic condition, seemingly small adjustments to formulations can have a significant improvement on quality of life,” said Florian Bieber, global head biopharmaceuticals development, Sandoz.

“Today’s positive opinion from the CHMP brings us closer to providing a treatment choice to patients that offers increased convenience and a reduction in injection volume,” Bieber added.

Supporting the company’s submission was a phase 1 pharmacokinetic bridging study comparing its approved 50mg/mL concentration with the HCF.

The study met all primary endpoints, demonstrating comparable pharmacokinetics and similar safety and immunogenicity between the two concentrations.

The 50mg/mL concentration of Hyrimoz was also approved in 2018 by the US Food and Drug Administration, which accepted the company’s application for the HCF in July last year.

Sandoz, which has a total of eight marketed biosimilars and over 15 in various stages of development, signed an agreement earlier this month to acquire worldwide product rights for leading systemic antifungal agent Mycamine (micafungin sodium) from Astellas.

The company’s chief executive officer, Richard Saynor, said at the time that the acquisition would “significantly reinforce the Sandoz global hospital offering, as well as complement [its] existing global leadership position in generic antibiotics.

“This will also be an important addition to our growing portfolio of anti-infective therapies aimed at combating the spread of antimicrobial resistance, by providing the right drug to the right patient at the right time.”

Sandoz also successfully completed its acquisition of GSK’s global cephalosporins portfolio in October 2021.

Article by
Emily Kimber

30th January 2023

From: Regulatory



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