FDA reviews Sandoz higher dose Humira biosim

July 22, 2022

Sandoz announced that the U.S. FDA has accepted its sBLA for a high concentration formulation (100 mg/mL) of Hyrimoz, a biosimilar to AbbVie's mega-blockbuster, Humira.

The application includes the Humira indications not protected by orphan exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

The lower concentration Hyrimoz formulation (50 mg/ML) was approved by the EMA in July 2018 and the FDA in Oct. 2018. Sandoz announced last month that the EMA had accepted its application for the higher dose formulation. 

In what's being touted as a 'watershed moment' for biosimilars, 7 FDA approved versions referencing top-selling drug Humira are set to launch in 2023.