Fourth Ustekinumab Biosimilar, Otulfi, Approved in US
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 …
FDA Approves Steqeyma: The Seventh Stelara Biosimilar
Dec 18, 2024 · The approval represents the seventh biosimilar approval for a Stelara competitor. 2 Steqeyma follows Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi …
FDA Approves Imuldosa, a Biosimilar to Stelara
Oct 11, 2024 · Stelara is one of the highest-grossing biologics in the US, generating $10.86 billion globally in 2023. Additionally, US sales for Stelara reached $6.4 billion in 2022, according to …
FDA Approves First Denosumab Biosimilars - Center for Biosimilars
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 …
Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar …
Dec 11, 2024 · Sandoz's biosimilar denosumab (Jubbonti/Wyost; denosumab-bddz) has demonstrated analytical, pharmacokinetic (PK), pharmacodynamic (PD), and clinical …
Health Canada Approves First Omalizumab Biosimilar
Dec 16, 2024 · Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with …
Top 5 Most-Read Regulatory Articles of 2024
Dec 25, 2024 · In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars …
Sandoz Report: A Unified Approach to Overcoming Drug Shortages
Oct 10, 2024 · With drug shortages for chemotherapy drugs and generic medications are impacting over 90% of hospital systems nationwide, all stakeholders will need to collaborate …
FDA Approves First Subcutaneous Infliximab Product - Center for …
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 …
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, …
Dec 4, 2024 · Biosimilars have gained success in recent years, with increased payer preference and market share, leading to significant price reductions and evidence of a competitive market …