It is the first tocilizumab biosimilar approved by the FDA. The reference product, Actemra (Genentech), was first approved by the agency in 2010. "The approval of Tofidence in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to lead...
In addition to trastuzumab-dkst, FDA has also approved a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Called bevacizumab-awwb (Mvasi), the biosimilar could reach the US market by 2020, after the patent on bevacizumab expires. And in May, FDA approved the...
PYZCHIVA becomes Samsung Bioepis’ seventh biosimilar and fourth immunology biosimilar approved by the FDA PYZCHIVA’s licensing period will begin on February 22, 2025, in the United States, based on the settlement and licensing agreement with Janssen Biotech Inc. ...
First Biosimilar Finally Approved by FDALEGAL COMPLIANCEQuestions loom over other approvals and pharmacist substitutionsEarlier this...Milenkovich, Ned
A fourth trastuzumab biosimilar has been granted approval by the FDA. The approval was for PF-05280014 for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma....
BySkylar Jeremias News Article The FDA approved Bkemv (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability. The FDAapprovedBkemv (eculizuamb-aeeb), the first biosimilar to reference Soliris (eculizumab), for the tr...
Ustekinumab-aauz is the fourth biosimilar for ustekinumab to be approved by the FDA. The FDA approved ustekinumab-aekn (Selarsdi; Teva Pharmaceuticals, Alvotech) for subcutaneous use as a biosimilar to ustekinumab in April 2024 and ustekinumab-ttwe (Pyzchiva; Sandoz, Samsung Bioepis) in July 202...
Cyltezois a biosimilar of AbbVie'sHumira(adalimumab).Cyltezois administered by subcutaneous injection (40 mg/0.8 mL). This is the second FDA-approved biosimilar to Humira; adalimumab-atto (Amjevita, Amgen, Inc) was the first, approved in September 2016, asreportedbyMedscape Medical News. ...
WASHINGTON, May 15 (Xinhua) -- The U.S. Food and Drug Administration (FDA) approved on Tuesday a biosimilar to epoetin alfa (Epogen or Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. ...
today announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva®* (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion. Developed by Samsung Bioepi...