Sandoz sBLA accepted by US FDA for biosimilar Hyrimoz

Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis (NOVN: VX), today announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab-adaz).

The application includes the indications of the reference medicine Humira (adalimumab), a mega blockbuster product from AbbVie (NYSE: ABBV), not protected by orphan exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Biosimilars of Humira have already appeared on European markets, but AbbVie has so far managed to stave off competition in the USA, entering deals with the likes of Icelandic biosimilars developer Alvotech and Sandoz to agree that launches are delayed until at least July 2023. Until being taken over by recent COVID-19 vaccines revenues, Humira, indicated in a dozen or more inflammatory diseases, was the world’s best-ever selling drug, and still generated global revenues of more than $4.7 billion in the first quarter of this year.