FDA Approves Samsung Bioepis' Stelara Biosimilar

Samsung Bioepis announced that the U.S. Food and Drug Administration (FDA) has approved Pyzchiva (ustekinumab—ttwe), a biosimilar version of Johnson & Johnson’s (J&J) popular immunotherapy, Stelara. This approval marks a significant development for patients with inflammatory conditions.

Pyzchiva has been approved for the treatment of severe plaque psoriasis in patients eligible for systemic therapy or phototherapy. In addition, it has received indications for active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. The biosimilar has also been granted a provisional determination for interchangeability and will be marketed in the U.S. by Sandoz.

Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis, emphasized the significance of the FDA approval. He stated that the availability of Pyzchiva as a biosimilar to Stelara represents an important milestone for patients living with inflammatory conditions. Biosimilars can potentially offer more choices and improve access to biologic treatments, reducing the financial burden on healthcare systems, particularly in the U.S., where biologics account for a large portion of annual drug spending.

Samsung settled all patent disputes with J&J in November 2023, clearing the path for Pyzchiva’s entry into the U.S. market. As part of the settlement, the licensing period for Pyzchiva will commence on February 22, 2025. The specific terms of the agreement between Samsung and J&J remain confidential.

Pyzchiva will encounter competition from other Stelara biosimilars, including one from Alvotech and Teva Pharmaceuticals, which is also set to enter the U.S. market in February 2025 following a settlement with J&J. Additionally, Amgen’s Stelara biosimilar is expected to launch at the same time under an agreement with J&J.

In J&J’s first-quarter 2024 earnings report, Stelara maintained its blockbuster status, generating over $2.4 billion in revenue. However, this figure fell short of Wall Street analysts’ expectations, who had estimated $2.6 billion for the quarter. J&J attributed the revenue miss to an “unfavorable patient mix” during its investor presentation.