FDA approves Yuflyma, a Humira biosimilar
Biosimilars are typically sold at lower prices than their reference medication
The U.S. Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high concentration biosimilar of Humira (adalimumab), for the treatment of ankylosing spondylitis.
Other approved indications for Yuflyma are rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
According to Celltrion Healthcare, which markets Yuflyma, the citrate-free formulation will be available in the U.S. in July, at a dosage of 40 mg in each 0.4 mL. It will offer patients pre-filled syringes and auto-injector administration options according to their preferences and needs.
The company plans to launch two more dosages: 80mg/0.8 mL and 20 mg/0.2 mL.
As a biosimilar, Yuflyma has similar properties, safety, and efficacy to the approved biological treatment. Biosimilars are typically sold at lower prices than their reference medication, as occurs for generic forms of medications.
“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,” Tom Nusbickel, chief commercial officer at Celltrion USA, said in a press release.
Ankylosing spondylitis (AS) is a chronic disease characterized by inflammation of the sacroiliac joints, where the base of the spine (the sacrum) meets the pelvis (iliac bone). Patients typically experience pain, stiffness, and trouble with movement.
The active component in Yuflyma and Humira is adalimumab, an antibody that blocks the activity of tumor necrosis factor-alpha (TNF-alpha), a protein produced by immune cells that’s involved in the inflammatory process that occurs in AS and other diseases. By blocking TNF-alpha, adalimumab reduces inflammation and helps relieve the symptoms of AS.
“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication,” said Jonathan Kay, MD, professor at UMass Chan Medical School. “The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy.”
Citrate-free formulations have been shown to reduce the pain associated with injection. According to Celltrion, Yuflyma was the first proposed high-concentration, low-volume, and citrate-free biosimilar of adalimumab approved in the European Union.
Basis of FDA approval
The company stated that the FDA approval was based on analytical, preclinical, and clinical data demonstrating that Yuflyma is comparable to the reference treatment. Particularly, it was found to have similar efficacy, safety, pharmacokinetics (the way it moves into, through and out of body) and effect on the immune response up to 24 weeks (nearly six months) and one year after treatment.
Celltrion also is seeking the FDA’s interchangeability designation for Yuflyma, which could be obtained by the end of 2024. When a biosimilar receives this designation, it may substitute the reference biological product at the pharmacy level. An interchangeable biosimilar does not pose additional risk and does not have reduced efficacy when a patient is switched back and forth between the reference product and the biosimilar.
“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 U.S. patients,” Nusbickel said.