Sixth Stelara Biosimilar, Yesintek, Approved by FDA

Biocon Biologics Ltd. announced today the FDA approval of Yesintek (ustekinumab-kfce), a sixth Stelara (ustekinumab) biosimilar, for the treatment of patients with inflammatory bowel disease, plaque psoriasis and psoriatic arthritis, according to the details of a news release. Yesintek will be available no later than Feb. 22, 2025 in the United States.

Yesintek is a monoclonal antibody, which are artificial proteins that are meant to stimulate the immune system, according to the National Cancer Institute.

Launch date is based on a licensing agreement between Biocon Biologics, Janssen Sciences Ireland and Johnson & Johnson. Although the patents for ustekinumab began expiring in 2023, licensing agreements prevent its biosimilars from being released in the United States until next year.

Stelara was originally approved by the FDA in September 2009 for the treatment of adults with moderate to severe psoriasis.

In addition to Yesintek, the other Stelara biosimilars are:

• Imuldosa (ustekinumab-srlf) approved in Oct. 2024
• Otulfi (ustekinumab-aauz) approved in Sept. 2024
• Pyzchiva (ustekinumab-ttwe) approved in June 2024
• Selarsdi (ustekinumab-aekn) approved in April 2024
• Wezlana (ustekinumab-auub) approved in Oct. 2023

Stelara, developed by Janssen, a Johnson & Johnson company, is a high-cost drug with a list price of $13,836 for one month’s supply. It generated $10.86 billion in revenue globally in 2023 compared with $6.4 billion the previous year. Stelara is available for $5 a dose for eligible patients through the savings program Stelara withMe.

Stelara is one of the drugs soon to be discounted under the Inflation Reduction Act. Starting in 2026, Medicare members will be able to get a 30-day supply for 66% off list price, costing $4,695.