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FDA Approves Biosimilar Wezlana for Several Inflammatory Conditions

The new drug is interchangeable with Stelara (ustekinumab), offering a new treatment option for people with plaque psoriasis, Crohn's disease, and other conditions.

On October 31, the FDA announced the approval of Wezlana (ustekinumab-auub), a biosimilar medication to Stelara for adults with moderate to severe plaque psoriasis or psoriatic arthritis, and active Crohn's disease or ulcerative colitis. The drug, developed by Amgen, Inc., is also approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis in children six and older.

Wezlana is a biological product that has no meaningful differences from Stelara. It is also interchangeable, which means the drug has met specific requirements that allow pharmacists to substitute Wezlana for Stelara without consulting the prescribing physician. This substitution process is similar to pharmacists exchanging generic drugs for brand-name medications.

The FDA approved Wezlana based on a thorough review of evidence, including a Phase 3 trial, which showed no differences in safety and effectiveness compared to Stelara. In addition, evidence obtained from chemical and biological tests and biological assays found both drugs share similar structural and functional features.

The agency also reviewed comparative pharmacokinetic data, immunogenicity data, and other clinical safety and effectiveness information before approving Wezlana.

Infection is the most serious known side effect of the new drug. Other side effects include headache, fatigue, nausea, vaginal yeast infections, and abdominal pain.

However, in clinical studies, some participants taking Wezlana reported malignancies, hypersensitivity reactions, and Posterior Reversible Encephalopathy Syndrome — a condition that causes headache, seizures, mental changes, and vision loss. Therefore, the drug's prescribing information will include a warning about these potential adverse events.

Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, said, "Today's approval exemplifies the FDA's longstanding commitment to support a competitive marketplace for biological products. This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost."


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