FDA greenlight for Samsung Bioepis’ biosimilar to Stelara

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe) submitted by South Korean firm Samsung Bioepis.

The subcutaneous injection and intravenous infusion is a biosimilar to US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Stelara (ustekinumab), which generated US sales of $1.4 billion in the first quarter of this year.

Pyzchiva has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. Additionally, a provisional determination was granted for Pyzchiva’s interchangeability.