Celltrion USA has secured approval from the US Food and Drug Administration (FDA) for its Yuflyma (adalimumab-aaty), which is a high-concentration (100mg/mL) and citrate-free formulation of Humira (adalimumab) biosimilar.

Yuflyma is now approved to treat eight conditions, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

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

The citrate-free formulation is said to be Celltrion’s fifth biosimilar and second anti-TNF biosimilar approved for use in the US.

Expected to be available in the US in 40 mg/.4 mL dosage from July this year, the drug will be given via a pre-filled syringe as well as an autoinjector alternative to satisfy each patient’s different preferences and needs.

Celltrion USA chief commercial officer Tom Nusbickel said: “Yuflyma offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients. It represents a key treatment option in patient care and patient choice.

“As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to expand the availability of high-quality biosimilars for US patients.”

The FDA approval was backed by a comprehensive pack of data from preclinical, clinical, and analytical studies.

These findings showed that Yuflyma was comparable to the reference drug regarding safety, efficacy, immunogenicity, and pharmacokinetics up to 24 weeks and one-year post-treatment.

Additionally, the company is planning to obtain FDA interchangeability designation for Yuflyma, which is tentatively anticipated in Q4 2024.

The drug is claimed to be the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission (EC) approval in Europe.

Celltrion also has plans to launch 80 mg/.8 mL and 20 mg/.2 mL Humira biosimilar in the future.

In August last year, Celltrion Healthcare obtained EC approval for Vegzelma (CT-P16).