24 May 2023 - - The US Food and Drug Administration has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira (adalimumab) biosimilar, US-based Celltrion USA said.

The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Yuflyma is Celltrion's fifth biosimilar and second anti-TNF biosimilar approved for use in the United States. Yuflyma will offer patients pre-filled syringe and autoinjector administration options to meet different preferences and needs.

The approval of Yuflyma was based on a comprehensive data package of analytical, preclinical, and clinical studies, demonstrating that Yuflyma is comparable to the reference product in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and one year following treatment.

Yuflyma will be available to patients in the US starting July 2023.

Celltrion is also seeking an interchangeability designation from the US FDA for Yuflyma, which is tentatively expected Q4 2024.

Yuflyma was the world's first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe.

Yuflyma is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa.

Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody.

Following the launch of 40mg/0.4mL, in the US in July 2023, Celltrion additionally plans to launch two different types of dosage forms 80mg/0.8mL, 20mg/0.2mL.

An interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by law, and often require additional clinical studies, which demonstrate that there is no additional risk or reduced drug effectiveness if a patient switches back and forth between an interchangeable biosimilar and a reference product, as compared to receiving treatment with just the reference product.

When a biosimilar receives an interchangeability designation by the FDA, that means the biosimilar product may be substituted for the reference product without the prescriber having to change the prescription.

The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called "pharmacy-level substitution" -- similar to how generic drugs are substituted for brand name drugs.

Patients treated with YUFLYMA are at increased risk for developing serious infections that may lead to hospitalization or death.

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies.

Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice and the EU GMP guidelines.

Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries.

Celltrion USA is Celltrion Healthcare's US subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for US patients.

Celltrion currently has five biosimilars approved by the US FDA: Inflectra (infliximab-dyyb), Truxima (rituximab-abbs), Herzuma (trastuzumab-pkrb), Vegzelma (bevacizumab-adcd), and Yuflyma(adalimumab-aaty).

Celltrion USA will continue to leverage Celltrion Healthcare's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for US patients.