FDA Approves Third Stelara Biosimilar


Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe) will be available beginning Feb. 22, 2025 and will be marketed by Sandoz.

The FDA has approved the biologics license application (BLA) for Pyzchiva (ustekinumab-ttwe) as a biosimilar to Janssen’s Biotech’s Stelara (ustekinumab). Pyzchiva marketing begins Feb. 22, 2025, based on a licensing agreement with Janssen.

Developed by Samsung Bioepis, Pyzchiva will be available as a subcutaneous injection and an intravenous infusion. It has been approved for the treatment of 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. Additionally, a provisional determination was granted for Pyzchiva’s interchangeability.

Pyzchiva will be commercialized by Sandoz in the United States. Samsung Bioepis has seven biosimilars approved in the United States and four commercially available as of June 2024.

Byoung In Jung

Byoung In Jung

“Biosimilars have a potential to reduce the financial burden of healthcare systems, especially in the United States where biologics account for more than 46% of the annual drug spending,” Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in a news release.

The approval of Pyzchiva was based a totality of evidence including analytical, non-clinical and clinical data demonstrating biosimilarity to Stelara. This includes a single-dose phase 1 clinical study that demonstrated pharmacokinetics (PK) equivalence and comparable safety, tolerability, immunogenicity in healthy volunteers and a phase 3 clinical study that demonstrated biosimilarity through equivalent efficacy and comparable safety.

The results of the phase 3 study was published in the Journal of the American Academy of Dermatology and were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in March 2024.

So far, the FDA has approved two other biosimilars of Stelara. The most recent was Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) in April 2024. The first Stelara biosimilar was Amgen’s Wezlana (ustekinumab-auub) approved in November 2023. Wezlana was also approved with interchangeability.

At least four other Stelara biosimilars are under FDA review, including Accord BioPharma’s DMB-3115, Fresenius Kabi and Formycon’s FYB202, Celltrion’s CT-P43, and Biocon’s BMAB-1200. Several other Stelara biosimilars are still in development.

Related: New Biosimilars Continue to be Approved But Uptake Varies by Class

Biosimilars launched to date account for 23% of molecule volume, but uptake has varied across therapeutic areas, according to the newest Use of Medicines report by IQVIA Institute for Human Data Science.

For example, uptake of biosimilars on the market for at least three years varies from 8% for insulin lispro to 82% for bevacizumab, which are biosimilars of Avastin.

Projecting to 2028, IQVIA predicts biosimilars will contribute to net price growth declines between 1% and 4%. Over the next five years, several branded biologics are expected to lose patent protection. The report predicted that loss of exclusivity for biologics and small generics will result in $93.6 billion in spending reductions by 2028.

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