FDA Approves Yesintek, a Biosimilar to Stelara
Biocon Biologics Ltd, announced that the U.S. Food and Drug Administration (FDA) has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference product, Stelara® (ustekinumab).
Yesintek, a monoclonal antibody, is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. As a human interleukin-12 and -23 antagonist, Yesintek is indicated in the treatment of:
Adult patients with:
- moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.
- active psoriatic arthritis (PsA).
- moderately to severely active Crohn’s disease (CD).
- moderately to severely active ulcerative colitis.
Pediatric patients 6 years and older with:
- moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
- active psoriatic arthritis (PsA).
Source: Biocon Biologics Ltd.
