Samsung Bioepis Co. has officially launched PYZCHIVA, its biosimilar version of Johnson & Johnson’s blockbuster drug Stelara, across the United States. The product became available on February 24 in multiple formulations including pre-filled syringes, intravenous infusion vials, and subcutaneous vials.
The biosimilar has been approved for the same inflammatory conditions as the reference drug, including moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Commercialization partner Sandoz is handling distribution following an agreement struck between the companies in September 2023.
Linda Y. MacDonald, executive vice president at Samsung Bioepis, noted that the launch represents an opportunity to expand treatment options and reduce healthcare costs. Under a settlement with J&J’s Janssen Biotech unit, Samsung Bioepis’ license period for PYZCHIVA in the US market begins February 22, 2025.
The South Korean company has been building a substantial presence in the biosimilar market with 11 products in its portfolio spanning multiple therapeutic areas. It currently has 10 biosimilars approved in the US market with five commercially available.
Biosimilars like PYZCHIVA typically enter the market at lower price points than their reference products, potentially offering savings for patients and healthcare systems while maintaining comparable efficacy and safety profiles. The original Stelara has been a major revenue generator for J&J, making it an attractive target for biosimilar developers.
