FDA approves Wezlana, interchangeable biosimilar of Stelara

The US Food and Drug Administration (FDA) yesterday announced it has approved US biotech major Amgen’s (Nasdaq: AMGN) Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

Wezlana, like Johnson & Johnson’s (NYSE: JNJ) ~$10 billion a year Stelara - the patent on which lapses later this year, is approved to treat adult patients with: 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.

It is also indicated for pediatric patients six years of age and older with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis.