FDA Approves Wezlana for Multiple Inflammatory Diseases

Follow Drugslib on

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 2, 2023.

By Lori Solomon HealthDay Reporter

THURSDAY, Nov. 2, 2023 -- The U.S. Food and Drug Administration has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

The approval includes indications for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn disease, and moderately to severely active ulcerative colitis. Additionally, the approval includes indications for pediatric patients (aged 6 years and older) with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and those with active psoriatic arthritis.

Approval of Wezlana was based on a review of scientific evidence that showed it is highly similar to Stelara in terms of safety, purity, and potency. Evidence from chemical and biological tests and biological assays confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy). Additionally, evidence included comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. Infection is the most serious known side effect in both drugs.

"Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases," Nikolay Nikolov, M.D., from the FDA Center for Drug Evaluation and Research, said in a statement. "Today's approval could have a meaningful impact for patients managing their disease."

Approval of Wezlana was granted to Amgen.

More Information

Source: HealthDay

Posted : 2023-11-03 08:30

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords