FDA Approves Pyzchiva, A Biosimilar To Stelara
(RTTNews) - Sandoz Group AG (SDZNY.OB), a Swiss company that focuses on generic pharmaceuticals and biosimilars, today announced the approval of Pyzchiva.
The FDA has granted approval to Pyzchiva, a biosimilar to the reference medicine Stelara. The drug has also been granted provisional determination for interchangeability designation.
Developed by Samsung Bioepis Co., Ltd., Pyzchiva, is approved for a range of conditions including moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severely active Crohn's disease, and ulcerative colitis.
The drug is available in pre-filled syringes for subcutaneous injection at strengths of 45 mg/0.5 mL and 90 mg/mL, as well as in single-dose vials for intravenous infusion at a strength of 130 mg/26 mL (5 mg/mL).
Sandoz plans to introduce Pyzchiva in the United States by February 2025, as outlined in the settlement and license agreement with Janssen Biotech Inc., previously disclosed by Samsung Bioepis Co., Ltd.
SDZNY.OB has traded in a range of $25.71 to $37.12 in the last 1 year. The stock closed Friday's trading (June 28, 2024) at $36.20, down 0.82%.
