…………catching up on FDA approvals
The FDA has approved a new therapy, Pyzchiva (ustekinumab-ttwe) from Samsung Bioepis, as a biosimilar to Janssen Biotech’s Stelara. Pyzchiva is available in a subcutaneous form as well as an infusible. Pyzchiva joins the ranks of only a handful of biosimilars to earn the title of interchangeability with the reference product.
The approval of Pyzchiva marks the third ustekinumab approval for the US as well as the 14th interchangeable biosimilar.
Pyzchiva is indicated for—–
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.
- Pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis.
Prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while also specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.
CLICK HERE for prescribing information
While Pyzchiva did not receive a Black Box warning there are a number of warnings and precautions.
Pyzchiva will launch in early 2025 when Stelara’s patent exclusivity expires. As such, pricing and distribution plans were not announced.
