Samsung Bioepis的Pyzchiva进入两大美国PBM优先药物清单

Samsung Bioepis has secured preferred drug status for Pyzchiva (SB17), a biosimilar of the autoimmune treatment Stelara, on the formularies of two major U.S. pharmacy benefit managers (PBMs). As prescription switching accelerates in the U.S. private insurance market, the move is expected to add momentum to the company's push into the local market, estimated at 10 trillion won annually.
According to industry sources on the 12th, CVS Caremark listed Samsung Bioepis's Pyzchiva as a preferred drug on the 1st of this month. Following its addition to the formulary of Express Scripts (ESI) earlier this year, the company has now secured preferred drug status at two major U.S. PBMs. Meanwhile, Stelara, the original drug for Pyzchiva, was excluded from major formularies.
PBMs are organizations that manage drug prescription lists, drug pricing, and reimbursement terms on behalf of insurers. When a drug is listed as preferred on a PBM formulary, patient access improves through insurance coverage, increasing the likelihood that it leads to prescriptions and sales by medical providers. As of 2025, ESI and CVS Caremark hold about 57% of the U.S. PBM market. As a result, the prescription switch from Stelara to Pyzchiva is expected to accelerate.
Stelara (generic name ustekinumab) is Johnson & Johnson's (J&J) autoimmune treatment that inhibits the activity of interleukin (IL)-12 and IL-23, signaling substances involved in immune response. It is prescribed for plaque psoriasis, psoriatic arthritis, and ulcerative colitis. As of 2024, Stelara's annual revenue reached $10.361 billion (about 15 trillion won), of which U.S. sales amounted to $6.72 billion (about 10 trillion won). Samsung Bioepis received marketing approval for Pyzchiva from the U.S. Food and Drug Administration (FDA) in June 2024, and has been selling the product since last year through its marketing partner Sandoz.
Samsung Bioepis is also supplying a private-label (PL) version of Pyzchiva through the distribution subsidiaries of these PBMs. Last year, the company signed PL contracts for Pyzchiva with Quallent, a subsidiary of ESI, and Cordavis, a subsidiary of CVS Caremark. PL is a method in which a biosimilar developer supplies products under the private brand of a PBM affiliate. PBMs are likely to prioritize listing PL products they directly distribute on their formularies, thereby encouraging prescription switching from original drugs. This is the first case in the biosimilar industry of a company signing PL supply contracts with two of the top three U.S. PBMs and being listed on their formularies. "Following the full-scale launch of PL product sales, we have now secured preferred drug status on PBM formularies, which will rapidly expand Pyzchiva's U.S. market revenue," a Samsung Bioepis official said.
Since Stelara's U.S. substance patent expired in 2023, biosimilar launches have gained momentum since last year. FDA-approved Stelara biosimilars now total eight, including Pyzchiva, Amgen's Wezlana, Dong-A ST's Imuldosa, and Celltrion's Steqeyma. "With competing products launching one after another, securing preferred drug status on PBM formularies is key to gaining first-mover advantage in the market," one industry official said.
Meanwhile, CVS Caremark has previously demonstrated the influence of PBM formulary listings in the prescription switching process for Humira, another autoimmune treatment. After excluding Humira from its formulary in 2024, CVS Caremark switched more than 90% of eligible patients to biosimilars. As a result, U.S. sales of the original drug fell from $18.6 billion (about 28 trillion won) in 2022 to $7.1 billion (about 11 trillion won) in 2024. Humira is a blockbuster drug that ranked No. 1 in global pharmaceutical sales for nine consecutive years from 2012 to 2020.