FDA approves ustekinumab-ttwe as biosimilar for pediatric plaque psoriasis, active psoriatic arthritis

FDA approves ustekinumab-ttwe as biosimilar for pediatric plaque psoriasis, active psoriatic arthritis | Image Credit: © Calin - © Calin - stock.adobe.com.

On July 1, 2024, the FDA approved biosimilar ustekinumab-ttwe (Pyzchiva; Samsung Bioepis) for all indications of its reference medicine, ustekinumab (Stelara; Johnson & Johnson), including the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older.

According to a press release from Sandoz, the company commercializing the biosimilar in the United States, ustekinumab-ttwe is also indicated for adults with moderately to severely active Chrohn's disease and adults with moderately to severely active ulcerative colitis.

An intentional launch date for ustekinumab-ttwe in the United States is set for sometime in February 2025, in accordance with the settlement and license agreement with Janssen Biotech Inc. Ustekinumab-ttwe "is expected to be among the first wave of ustekinumab biosimilars to launch in the US," according to Sandoz.

"By further expanding our immunology portfolio with affordable biosimilar alternatives, we continue to make significant strides towards achieving our goal of delivering life-changing medicines to the patients who need them," said Claire D'Abreu-Hayling, chief scientific officer, Sandoz, in a statement.

Approval was granted to Samsung Bioepis based on clinical studies that demonstrated equivalent efficacy and comparability to the reference medicine.

"Systemic medications like biologics are a key treatment option for many people to manage symptoms of psoriasis and psoriatic arthritis," said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation, in the press release.

"Unfortunately, barriers to care, including costs, often prevent patients from getting the drug they are prescribed. Psoriatic disease is lifelong and chronic, leading to long-term treatment costs. Having more FDA-approved options can help make appropriate healthcare more affordable," said Howard.

Ustekinumab-ttwe is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.

According to Sandoz, the most common adverse reactions are include, "Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. Crohn’s Disease, induction (≥3%): vomiting. Crohn’s Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. Ulcerative colitis, induction (≥3%): nasopharyngitis. Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea."

Reference:

FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialized by Sandoz in US. Sandoz. Press release. July 1, 2024. Accessed July 9, 2024. https://www.sandoz.com/fda-approves-biosimilar-pyzchivar-ustekinumab-ttwe-be-commercialized-sandoz-us/