Fresenius Kabi Launches Otulfi, the 4th Biosimilar of Stelara to Become Available

Fresenius Kabi has launched the biosimilar Otulfi (ustekinumab-aauz)in the United States. Otulfi is a biosimilar that references Johnson & Johnson’s Stelara (ustekinumab).

The FDA had approved Otulfi in September 2024 to treat patients six years of age and older with Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Otulfi is available in subcutaneous and intravenous formulations as 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL single dose vial for IV infusion. Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA approval in the first half of 2025.

The FDA has also granted a provisional determination of interchangeability for Otulfi, according to Sang-Jin Pak, president, Biopharma, at Fresenius Kabi.

The company has not responded to requests for information about pricing.

Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis, and inflammatory diseases like Crohn’s disease and ulcerative colitis.

The development and commercialization of Otulfi is the first biosimilar product launched in the United States from the partnership between Fresenius and Formycon.

Seven biosimilars that reference Stelara have been approved by the FDA. Four have been launched, in addition to Otulfi.

In January, Amgen’s Wezlana (ustekinumab-auub) launched. Wezlana is available only through Optum, a division of UnitedHealth Group. A high- and low-list price version of Wezlana has been available on Optum Rx’s commercial formularies since Jan. 1, 2025. Amgen offers a $0 copay program for commercially insured patients.

In February, three additional biosimilars launched. Teva and Alvotech it’s biosimilar Selarsdi (ustekinumab-aekn) at an 85% discount off Stelara, and eligible patients may receive their medication at no cost or may be eligible for assistance through Teva’s programs. Selarsdi, approved by the FDA in October 2024, is available as a single-dose prefilled syringe for subcutaneous injection and in a single-dose vial for intravenous infusion.

Additionally, last week Sandoz and Biocon Biologics each launched their biosimilar versions of Stelara. Pyzchiva (ustekinumab-ttwe), developed by Samsung Bioepis and commercialized by Sandoz, is expected to be interchangeable in the first half of 2025. Pyzchiva will be available at a list price that is 80% below the current Stelara list price, which is $25,497.12 every 8 weeks for the 90 mg dose.

Biocon Biologics’s Yesintek (ustekinumab-kfce) will have a wholesale acquisition cost (WAC) of approximately $3,000, reflecting about a 90% discount compared with Stelara's WAC, making it the lowest-priced ustekinumab biosimilar. A Biocon Biologics spokesperson said the company has had productive discussions with many payers, and they anticipate formulary announcements through March and April.

Sandoz and Biocon have indicated they are providing support resources for patients, including $0 copay programs for eligible patients. The terms of both Pychiva and Yesintek copay programs say the copay assistance is not available when accumulator adjustment or maximizer programs are applied.