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.

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 ...

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).

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 ...

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

Nov 7, 2024 · During the discussion, panelists emphasized the need for greater transparency and policy reforms within PBM practices to improve biosimilar access and competition. 16 The panelists advocated for simple reforms, such as fair access fees and formulary placement, to create a transparent, competitive market that supports biosimilar growth and cost savings.

Jan 27, 2025 · Patients with psoriasis who switched from reference ustekinumab to its biosimilar, SB17, experienced comparable long-term efficacy and safety, alleviating concerns about switching and promoting wider use of more affordable treatment options, according to a study published in the Journal of Dermatological Treatment. 1. Biologic treatments have improved efficacy and revolutionized the treatment ...

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.

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 ...