On 13 July 2026, Seoul Economic Daily reported that Samsung Bioepis has secured US formulary listings for Pyzchiva®/SB17, with two major pharmacy benefit managers (PBMs).
Pyzchiva® was listed as a preferred drug by CVS Caremark from 1 July 2026, following the inclusion of Pyzchiva® on the Express Scripts (ESI) formulary earlier this year. According to the announcement, CVS Caremark and ESI cover 57% of the US PBM market, broadening patient access.
Samsung Bioepis also supplies private label versions of Pyzchiva® through agreements with distribution subsidiaries of these PBMs, including Quallent (an ESI subsidiary) and Cordavis (a CVS Caremark subsidiary). The private label versions of Pyzchiva® are supplied under the proprietary brands of the PBM subsidiaries.
The reference drug, J&J’s Stelara® (ustekinumab) is excluded from major formularies in the US. In May 2026, it was reported that from 1 July 2026, CVS Health would preference lower-cost, interchangeable biosimilars over Stelara® in its most common drug lists. CVS Health’s pharmacy benefit management unit, Caremark, will transition to biosimilar versions of Stelara®, such as Sandoz/Samsung Bioepis’ Pyzchiva® and Biocon Biologics’ Yesintek™.
Pyzchiva® was developed by Samsung Bioepis and is commercialised by Sandoz in the US pursuant to a deal entered into in September 2023. The FDA approved Pyzchiva® in July 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.
There are currently seven other FDA-approved ustekinumab biosimilars in the US market: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (FDA-approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (FDA-approved April 2024; launched February 2025; interchangeability status May 2025), Biocon’s Yesintek® (FDA-approved in December 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (FDA-approved September 2024; launched March 2025), Celltrion’s Steqeyma® (FDA-approved December 2024; launched March 2025) and Hikma’s Starjemza™ (FDA-approved May 2025; launched November 2025).