Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

  • Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study
  • Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients
  • Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe

BASEL, Switzerland I June 17, 2022 I Sandoz, a global leader in generic and biosimilar medicines, today 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 uveitis1.

Upon approval, 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. 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,” said Florian Bieber, Global Head Biopharmaceuticals Development, Sandoz. “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.”

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. 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.

Sandoz is committed to helping millions of patients access biologic medicines sustainably in areas including oncology and immunology. With a strong portfolio of eight marketed biosimilars and a further 15+ in various stages of development, Sandoz has an unparalleled heritage and extensive expertise in the development, manufacturing and delivery of biosimilar medicines to patients and the healthcare community worldwide.

About adalimumab

Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). The adalimumab reference medicine (Humira®*) was first approved with an adalimumab concentration of 50 mg/mL.2,3 In 2015, the EMA and US FDA approved Humira® HCF, which contains adalimumab at a concentration of 100 mg/mL.4,5

About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.

References

1. EMA. Humira® EPAR Product Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/humira. [Accessed June 2022]

2. EMA. Hyrimoz® EPAR Product Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz.[Accessed June 2022]

SOURCE: Novartis

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