The approval in previously treated pediatric patients was based on data from the Alfa-PROTECT and PROTECT Kids studies.

The FDA originally approved Otulfi as a biosimilar in October 2024 based on clinical data that demonstrated the product was highly similar to Stelara.

The FDA also requested Novavax conduct a phase 4 study in patients aged 50 to 64 years without high-risk conditions for severe COVID-19.