Center for Biosimilars®
WEBSeptember 24th 2024. Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion in 2023, their potential is hindered by high patient costs, drug shortages, and ineffective policies, underscoring the need for reforms to fully realize their benefits.
Duke Publishes Recommendations for Developing CGT Biosimilars
WEB1 day ago · In light of high costs for current cell and gene therapies (CGTs) and promise of biosimilars to lower costs on biologic drugs, the Duke Margolis Institute for Health Policy published policy recommendations for developing a robust competitive market for biosimilar CGTs. 1. The FDA has approved numerous innovative cell and gene therapies ...
News - Center for Biosimilars
WEBSep 30, 2024 · AAM Report: Despite Massive Savings, Patient OOP Costs on Biosimilars, Generics Remain High, Part 2. Skylar Jeremias. September 24th 2024. Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion …
Fourth Ustekinumab Biosimilar, Otulfi, Approved in US
WEBSeptember 30, 2024. By Laura Joszt. News. Article. Otulfi was approved simultaneously in the European Union. In the US, it will launch in February 2025. Otulfi is the fourth FDA-approved ustekinumab (Stelara) biosimilar and was simultaneously approved by the European Commission. Image credit: wladimir1804 - stock.adobe.com.
AI and Biosimilars: Bridging Global Health Disparities and …
WEBAug 10, 2024 · Artificial intelligence (AI) technologies can aid global health systems in incorporating biosimilars into care models, lower health care costs, aid in treatment decision-making strategies, and bridge the gap between high-income and low- and middle-income nations, according to a review published in Pharmaceuticals (Basel). 1. Conducted to address the evolving landscape of biosimilars following ...
FDA Approves Semglee Insulin Glargine as First Interchangeable Biosimilar
WEBJul 29, 2021 · The FDA has approved Biocon Biologic's Semglee insulin glargine as an interchangeable biosimilar, referencing Lantus. The approval carries with it many hopes for stronger competition in the insulin market, which is dominated by a handful of brands and characterized by stubbornly high prices. The approval of Semglee was much anticipated; it …
Celltrion’s Infliximab Biobetter Shows Significant Clinical ...
WEBJun 4, 2022 · Results from the European Congress of Rheumatology’s annual meeting revealed that Celltrion’s Remsima SC, a subcutaneous biobetter infliximab product, produced better clinical outcomes compared with the original Remsima, an infliximab biosimilar delivered intravenously.
Development - Center for Biosimilars
WEBDeana Ferreri, PhD. January 2nd 2024. The regulatory structure of biosimilar development can be safely streamlined and made more efficient and less costly, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.
Part 1: Biosimilars to Bring a Bumper Crop of Adalimumab Options
WEBSep 6, 2022 · Readers can also check out part 2, part 3, part 4, podcast 1, and podcast 2 now.. For most of the decade, AbbVie’s Humira (adalimumab) has been the most profitable drug in the world. It took a global pandemic to knock the injectable biologic for inflammatory diseases into second place in 2021, but it still reached $20.7 billion in sales, topped only by Pfizer’s vaccine for COVID-19.
FDA Approves Coherus’ Cimerli as Interchangeable Biosimilar to …
WEBAug 3, 2022 · The Coherus biosimilar ranibizumab-eqrn, which references the injectable Lucentis, received FDA approval late Tuesday, bringing more competition to the ophthalmology market after years in which expensive injectable therapies for retinal conditions brought in billions in sales.. The vascular endothelial growth factor (VEGF) inhibitor, to be sold as Cimerli, was desginated as an interchangeable ...