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 11, 2024 · Patent litigation is often resource intensive on both sides. During an interview with The Center for Biosimilars, Ha Kung Wong, JD, an intellectual property attorney and partner at Venable, noted that the patent dance has been instrumental in promoting settlements, reducing the need for many cases to proceed to trial. 2 “The patent dance allows for an early assessment of infringement and ...

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 25, 2024 · In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.

Dec 24, 2024 · The top 5 oncology biosimilar articles in 2024 include key developments such as Duke's recommendations for cell and gene therapy (CGT) biosimilars, FDA approval of Shanghai Henlius Biotech's trastuzumab biosimilar, and a business recap featuring layoffs at Boehringer Ingelheim and a new partnership between Teva and mAbxience.

Jul 1, 2024 · Pyzchiva marks the third biosimilar referencing Stelara (ustekinumab) to be approved for the American market, and the biosimilar was approved with an interchangeability designation, allowing for it to be substituted for the reference product at the pharmacy level without waiting for physician approval.

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.

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 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 ...