Dec 18, 2024 · The approval represents the seventh biosimilar approval for a Stelara competitor. 2 Steqeyma follows Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce), the last of which was approved at the beginning of December 2024. 3 ...

Jul 17, 2023 · Throughout 2023, 9 FDA-approved adalimumab biosimilars are projected to enter the US market. As of the second week of July 2023, 8 had entered the market, beginning with Amgen’s Amjevita (adalimumab-atto) in January. Amjevita launched with a dual price strategy, where 2 versions of the drug would launch at 2 different prices (5% and 55% lower than the current price of Humira) to both entice ...

Nov 1, 2023 · The FDA approved Wezlana (ustekinumab-auub), making it the first approval for a biosimilar referencing blockbuster drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability designation.

Dec 11, 2024 · Sandoz's biosimilar denosumab (Jubbonti/Wyost; denosumab-bddz) has demonstrated analytical, pharmacokinetic (PK), pharmacodynamic (PD), and clinical equivalence to the reference denosumab (Prolia/Xgeva), justifying its approval and extrapolation to all indications, according to a study published in Clinical Therapeutics. 1. The narrative review summarized the totality of evidence for denosumab ...

Sep 30, 2024 · The FDA has approved the fourth ustekinumab biosimilar, ustekinumab-aauz (Otulfi) from Formycon and Fresenius Kabi, referencing Stelara (Johnson & Johnson [J&J]). 1 The approval covers Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Ustekinumab is a human monoclonal antibody targeting IL-12 and IL-23.

Mar 5, 2024 · The FDA has approved Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US. 1 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.. The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in February 2023.

Feb 24, 2024 · After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the company, the 10th biosimilar to reference Humira, and …

Oct 23, 2023 · The FDA approved Celltrion USA’s Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Zymfentra is approved as a novel drug, and its development is based on Remicade (reference intravenous infliximab).

Dec 19, 2023 · The FDA has approved the fifth bevacizumab biosimilar, Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) for the treatment of several types of cancer.. Avzivi is a humanized monoclonal antibody that inhibits vascular endothelial growth factor and references Genentech’s Avastin (bevacizumab).

Jan 31, 2023 · "With today's announcement, Amjevita is the first U.S. biosimilar to Humira®, a medicine used by more than a million patients living with certain serious inflammatory diseases,"said Murdo Gordon, executive vice president of global commercial operations at Amgen, in a statement.. The biosimilar is 1 of 10 adalimumab biosimilars expected to launch in 2023 and it will be the only adalimumab ...