UPDATE

Hyrimoz approval prepares US for a September 2023 launch

By Flora Southey contact

- Last updated on GMT

(Image: Getty/porcorex)
(Image: Getty/porcorex)

Related tags: Humira, AbbVie, Sandoz

The US FDA approval, coupled with a Humira licensing agreement, will see Sandoz’s biosimilar enter the market as of September 30, 2023.

The US Food and Drug Administration (FDA) has approved Sandoz’s biosimilar version of AbbVie’s best-selling Humira (adalimumab). Novartis’ subsidiary submitted​ Hyrimoz for FDA review in January 2018.

Hyrimoz is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

A Novartis spokesperson was unable to disclose Hyrimoz’s list price at this stage, but said “Hyrimoz has the potential to offer a high-quality lower cost treatment option that could potentially free-up financial resources to allow for greater investment in new, innovative treatments and provide expanded patient access to adalimumab.

“In the US, where 29 of the 50 most expensive treatments by Medicaid spending per prescription are biologics, biosimilar medicines are expected to deliver more than $44bn (€38.5bn) in savings by 2024,” ​the spokesperson added.

While patent protection currently prevents Hyrimoz from entering the US market, Sandoz signed a licensing agreement with AbbVie last month to facilitate a Hyrimoz launch in five years’ time.

Per the agreement, AbbVie will grant Sandoz a non-exclusive licence to intellectual property (IP) relating to Humira on September 30, 2023, in the US. AbbVie, therefore, is expected to continue to benefit from the blockbuster’s sales in the US for another five years – Humira brought in $18.43bn in sales last year.

AbbVie has similarly defended Humira from biosimilar competition from three other adalimumab developers in the US. According to the IP deals, Amgen​’s Humira alternative will have access to the US market on January 31, Samsung Bioepis​ on June 30, and Mylan​’s on July 31, 2023.

Hyrimoz is Sandoz’s third biosimilar to receive regulatory approval in the US, following its Neupogen biosimilar, Zarxio​ (filgrastim-sndz), and Enbrel alternative, Erelzi​ (etanercept-szzs).

Competition across the pond

In Europe, where Humira secured sales​ of $4.1bn for the 12 months ending December 31, 2017, the biologic is also attracting increased competition.

On October 16 2018, the day that AbbVie’s Humira patent protection expired in Europe, three Humira biosimilars​ entered the market: Sandoz’ Hyrimoz and Amgen’s Amgevita, shortly followed by Samsung Bioepis’ Imraldi​.

Related topics: Markets & Regulations, Biosimilars

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