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 FDA approved Celltrion's Steqeyma (ustekinumab-stba), making it the seventh biosimilar slated to compete against blockbuster Stelara (reference ustekinumab) in …
FDA Approves Biocon Biologics Ustekinumab Biosimilar, Yesintek
Dec 2, 2024 · The approval marks the sixth biosimilar to reference Stelara (ustekinumab), and it will be used to treat several immunology conditions, including psoriatic arthritis and …
Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar …
Dec 11, 2024 · Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab …
FDA Approves Pavblu for Retinal Conditions
Sep 17, 2024 · The FDA has approved Pavblu (aflibercept-ayyh), the fifth biosimilar referencing Eylea (aflibercept). 1 The new product is approved for the treatment of retinal conditions, …
FDA Approves First Denosumab Biosimilars - Center for Biosimilars
Mar 5, 2024 · Wyost/Jubonti is the first biosimilar to reference Amgen's Prolia/Xgeva to receive regulatory approval in the US. They are also the 47th and 48th biosimilars overall to approved …
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 …
BioRationality—The Evolution of the BPCIA and the Bright Future …
Oct 7, 2024 · The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have …
Breaking Down Biosimilar Barriers: Interchangeability
Nov 14, 2024 · Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, …
FDA Approves First Subcutaneous Infliximab Product - Center for …
Oct 23, 2023 · The FDA approved Celltrion’s Zymfentra (infliximab-dyyb), a novel drug that allows for subcutaneous administration of inflximab.