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 ...

Dec 2, 2024 · The biosimilar was developed by Karnataka, India–based Biocon Biologics and will likely launch in the second half of 2025, along with Otulfi (ustekinumab-aauz), Selarsdi (ustekinumab-aekn), Imuldosa (ustekinumab-srlf), and Pyzchiva (ustekinumab-ttwe).

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.

Sep 17, 2024 · Pavblu was developed by Amgen and comes shortly after the FDA approved Enzeevu (aflibercept-abzv) in August 2024. 2 All 5 aflibercept biosimilars were approved in 2024, beginning with Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis' Opuviz (aflibercept-yszy) in May 2024, followed by Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb) in July 2024 and Enzeevu. 3,4

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.

Nov 30, 2024 · Market Insights. Skyrizi (risankizumab-rzaa) has officially dethroned Humira (reference adalimumab) as AbbVie’s top seller, less than 2 years after adalimumab biosimilars hit the US market. 1 Despite a sharp rise in adalimumab biosimilar use, the overall market for adalimumab has shrunk, thanks to AbbVie shifting patients from one of its drugs to another to maintain market share—a strategy ...

Nov 6, 2024 · Currently, Celltrion USA has 6 biosimilars (infliximab, rituximab, trastuzumab, adalimumab, bevacizumab, on the US market, as well as Zymfentra, a novel product that allows for the subcutaneous administration of its infliximab biosimilar (Inflectra, Remsima).

The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market …

Jan 10, 2024 · The product was developed by Alvotech and will be marketed by STADA Arzneimittel as part of a 2019 exclusive commercialization agreement. Uzpruvo is expected to be available to patients following the July 2024 expiry of a European Supplementary Protection Certificate for Stelara.

Aug 12, 2024 · Sandoz secured another approval, this time for an aflibercept biosimilar. 1 Enzeevu (aflibercept-abzv) is the fourth biosimilar referencing Eylea and is approved to treat neovascular age-related macular degeneration (nAMD) and was granted interchangeability, allowing it to be substituted in place of the reference product at the pharmacy level without provider permission.