Burger line Burger line Burger line
Logo Logo Logo
Burger line Burger line Burger line
Menu
Sign in
Sign in

FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, Hyrimoz

FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, Hyrimoz

Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).

A version of this article was originally published on The Center for Biosimilars. This version has been lightly edited.

Sandoz said this week the the FDA approved its citrate-free, high-concentration formulation (HCF) of its adalimumab biosimilar, Hyrimoz.

The adalimumab-adaz injection (100 mg/mL) is approved to treat 7 indications covered by the reference product, Humira, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.

“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” Keren Haruvi, president, Sandoz Inc., head of North America, said in a statement.

Sandoz set a launch date of July 1 for both versions of Hyrimoz.

The FDA approval was based on a phase 1 pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free, HCF 100 mg/mL. This study met all of the primary objectives, demonstrating comparable PK and showing similar safety and immunogenicity of the low-concentration adalimumab and the HCF adalimumab.

The original, low-concentration version of Hyrimoz was approved by the FDA in 2018. Another HCF version, Hadlima, from Organon and Samsung Bioepis, was approved in July 2019. Biologics license applications for Alvotech and Celltrion Healthcare's high-concentration adalimumab biosimilars are currently under review with the FDA.

In 2023, up to 10 adalimumab biosimilars will enter the market. The first, Amgen’s Amjevita, launched at the end of January 2023; as with Hyrimoz, the others are scheduled to launch starting in July 2023.

Mar 24, 2023

https://www.ajmc.com/


0 items in Cart
Cart Subtotal:
Go to cart
You will be able to Pay Online or Request a Quote
Catalog
Services
Company

We use "cookies*  to ensure the functionality of our website, recognise your browser or device, learn more about your interests, and provide you with essential features and services and for additional purposes, including:

Recognising you when you sign-in to use our services. This allows us to provide you with product recommendations, display personalised content, and provide other customised features and services.
Keeping track of your specified preferences. You may set your preferences through Your Account..
Keeping track of items stored in your shopping basket and personal cabinet.
Conducting research and diagnostics to improve ChemDiv’s content, products, and services.
Delivering content, including ads, relevant to your interests on ChemDiv’s site
Reporting. This allows us to measure and analyse the performance of our services.

By  cookies you give consent to the processing of your personal data, including transfer to third parties. Further information can be found in our privacy policy.

Accept all cookies