FDA reviewing higher dose Hyrimoz biosimilar

By Jane Byrne contact

- Last updated on GMT

© GettyImages/ardaguldogan
© GettyImages/ardaguldogan

Related tags: Sandoz, Biosimilars, Humira, Hyrimoz

The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.

Hyrimoz HCF (adalimumab-adaz), if approved, would help expand access to more patients with serious inflammatory diseases, said Keren Haruvi, president, Sandoz Inc.

The sBLA includes the indications of the reference medicine, Humira, not protected by orphan exclusivity including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Market access

Hyrimoz 50 mg/mL was approved by the US Food and Drug Administration (FDA) in 2018.

Despite that approval, Hyrimoz will not be available to patients until 30 September 2023 due to legal resolution of a patent infringement litigation settled between AbbVie and Sandoz in 2018.

We ran a piece yesterday​ on some of the other market access hurdles that the seven Humira biosimilars launching in 2023 face.

Study data

Sandoz, the generics and biosimilars unit of Novartis, ran a Phase I pharmacokinetics (PK) bridging study to compare Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF, as part of its submission.

The findings, it confirmed, showed comparable pharmacokinetics and similar safety and immunogenicity between Hyrimoz 50 mg/mL and Hyrimoz HCF.

June this year saw the European Medicines Agency (EMA) also accept an application for Hyrimoz HCF.

Growing the biosimilars market

Meanwhile, last month saw Sandoz announce​ an initiative pushing for improved access for biosimilars.

The ‘Act4Biosimilars’ organization wants to see increased adoption of biosimilars by at least 30% in over 30 countries by 2030, by targeting ‘four As’: approvability, accessibility, acceptability and affordability.

Sandoz is the founding sponsor; the steering committee is comprised of patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders.

When asked about what steps Act4Biosimilars will take to achieve its goals, a spokesperson for Sandoz said it would “create solutions and resources for international and local country use; and take an active role in communicating the Act4Biosimilars mission, actions, and tools to decision-makers, peers, and other key stakeholders in their region/countries.”

The markets being targeted were selected based on an assessment of “each country’s level of biosimilar uptake, state of relevant policy environment and healthcare system characteristics.”

The list itself is made up of countries from across the globe, including certain countries that currently have limited access to biosimilar products, such as in South America and Africa.  

Related topics: Markets & Regulations, Biosimilars

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