Fresenius Kabi releases Stelara biosimilar
Fresenius Kabi is offering Otulfi (ustekinumab-aauz), which was developed by Formycon AG. The medication is a generic of Stelara.
Otulfi is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients, moderate to severely plaque psoriasis for adult patients and pediatric patients six years or older, who are candidates for phototherapy or systemic therapy, and active psoriatic arthritis in adults and pediatric patients six years or older.
The development and commercialization of the ustekinumab biosimilar is the first biosimilar product launched in the United States from the partnership between Fresenius and Formycon AG.
[Read more: FDA approves Dong-A ST’s Stelara biosimilar]
In February 2023, Fresenius and Formycon entered a global commercialization partnership for the ustekinumab biosimilar covering key global markets. The drug received FDA approval in September 2024.
“The U.S. availability of Otulfi demonstrates our commitment to serving patients and clinicians. Through the expansion of our biopharma portfolio, we are able to do this globally and, in the U.S.,” said Sang-Jin Pak, president biopharma and member of the Fresenius Kabi management board. “In addition to approving Otulfi last year for all indications matching the reference product Stelara, the FDA has also granted a provisional determination of interchangeability for Otulfi.”
Otulfi will be available in a 45 mg/0.5 ml and 90 mg/ml single-dose prefilled syringe for injection and a 130 mg/26 ml (5 mg/ml) single dose vial for IV infusion.
[Related: Fresenius Kabi, Formycon receive FDA nod for Stelara biosimilar]
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 company noted.