Hyrimoz HCF is approved in the US to treat indications including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa

injection-gba32bec30_640

Sandoz rolls-out Humira biosimilar Hyrimoz. (Credit: Myriams-Fotos from Pixabay)

Swiss drugmaker Novartis through its generic and biosimilars unit Sandoz has introduced Hyrimoz (adalimumab-adaz), its high-concentration formulation (HCF) biosimilar to AbbVie arthritis treatment Humira.

Hyrimoz HCF is approved in the US to treat all indications that do not fall under the regulatory exclusivity for the reference medicine, Humira (adalimumab).

The indications include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.

Sandoz said that its Hyrimoz HCF will reduce by 50% injection volume compared to the 50mg/mL concentration and can decrease the number of injections required for people who need at least 80mg/0.8mL dosing.

The HCF formulation is citrate free and uses the prefilled Sensoready pen, the same auto-injector used with Hyrimoz 50mg/mL.

The Sensoready pen is an ergonomic device that comes in a triangular shape, with buttonless injection for self-administration and offers a 360° viewing window for visual feedback.

Sandoz North America president Keren Haruvi said: “This is an important moment for Sandoz and for the millions of patients living with chronic inflammatory diseases in the US.

“With this launch, we are entering the US immunology market and continuing to fulfil our commitment to expand access to important medicines for patients.

“Sandoz has a long history of developing and marketing biosimilars that generate healthcare savings and enhance competition that drives innovation in the market.

“We are pleased to continue this legacy in the US with Hyrimoz, which offers another treatment option for those who need adalimumab but might have previously been unable to access or afford this critical medicine.”

Hyrimoz will be priced at a 5% lower than Humira’s current price of $6,922 per month, but also offering an unbranded version of Humira at an 81% discount, reported Reuters.

Amgen was the first to launch a biosimilar of Humira earlier this year, which commercialised the drug at a 5% to 55% lower price than Humira, based on the purchasers.

In a separate development, Organon, in partnership with Samsung Bioepis, has launched another biosimilar to AbbVie’s arthritis drug, dubbed Hadlima.

Hadlima will be offered at a price of $1,038 per month, which is 85% lower than Humira’s current monthly price.

Furthermore, Boehringer Ingelheim has announced the commercial launch of Cyltezo (adalimumab-adbm), its FDA-approved biosimilar to Humira.