Samsung Bioepis Gets FDA Approval for Biosimilar of J&J’s Stelara
01 Jul 2024
Drug ApprovalLicense out/inImmunotherapy
Pictured: Exterior of a Samsung location in San Jose, California/iStock, JHVEPhoto
Samsung Bioepis announced Monday that the FDA has approved Pyzchiva (ustekinumab—ttwe), a biosimilar of Johnson & Johnson’s blockbuster immunotherapy Stelara.
Pyzchiva is approved to treat severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy. The biosimilar is also indicated for active psoriatic arthritis, moderately to severely active Crohn’s disease, as well as moderately to severely active ulcerative colitis. Pyzchiva has also been granted a provisional determination for interchangeability and will be commercialized by SandozSandoz in the U.S.
“The FDA approval of Pyzchiva as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments,” Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in a statement. “Biosimilars can potentially reduce the financial burden of healthcare systems, especially in the U.S. where biologics account for more than 46% of the annual drug spending.”
Samsung settled all patent litigation with J&J in November 2023, paving the way for the biosimilar of Stelara to enter the U.S. market. The license period for Pyzchiva will begin on Feb. 22, 2025, as part of the deal, though the exact terms of the agreement between Samsung and J&J remain confidential.
However, Pyzchiva will face competition from a Stelara biosimilar from Alvotech and Teva Pharmaceuticals. That biosimilar’s entry into the U.S. market is also slated for February 2025 after reaching a settlement with J&J. Amgen’s Stelara biosimilar will also jump into the market that same month per an agreement with J&J.
During J&J’s first-quarter 2024 earnings, Stelara held on to its blockbuster status bringing in over $2.4 billion. However, sales were lower than expected by Wall Street analysts, who estimated $2.6 billion in the quarter, according to Reuters. J&J missed its Q1 revenue estimates and noted that Stelara faced an “unfavorable patient mix” during its investor presentation.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
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