FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

The U.S. Food and Drug Administration approved Amgen, Inc.’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications: 

• Adult patients with:

  • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy,

  • active psoriatic arthritis,

  • moderately to severely active Crohn’s disease; and

  • moderately to severely active ulcerative colitis.

• Pediatric patients 6 years of age and older with:

  • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and 

  • active psoriatic arthritis.

Healthcare professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, MD, director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”

What is a biosimilar? How does it work?

Biological products include medications for treating many serious illnesses and chronic health conditions. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (hence, also called the reference product). 

An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber. 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. 

All biological products are approved only after they meet the FDA’s rigorous approval standards. This means healthcare providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than branded medicine.

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

Safety and side effects of Wezlana

The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness). This evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed structural and functional similarities between Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. 

The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.

Like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions with ustekinumab products are:

• nasopharyngitis

• upper respiratory tract infection

• headache

• fatigue

• nausea

• vomiting

• injection site erythema

• vulvovaginal candidiasis/mycotic infection

• bronchitis

• pruritus

• urinary tract infection

• sinusitis

• abdominal pain

• influenza

• fever 

• diarrhea

The labeling for Wezlana, like Stelara, contains a warning to alert healthcare professionals and patients about an increased risk of serious infections leading to hospitalization. There is also a warning that some malignancies, hypersensitivity reactions, and cases of Posterior Reversible Encephalopathy Syndrome have been reported in patients who received Wezlana in clinical studies. Wezlana must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

- This press release was originally published on the U.S. Food and Drug Administration website