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centerforbiosimilars
14 小时
Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges
The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, ...
centerforbiosimilars
2 天
IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics
During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies ...
centerforbiosimilars
5 天
FDA Approves Imuldosa, a Biosimilar to Stelara
Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.
centerforbiosimilars
9 天
BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US
The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar ...
centerforbiosimilars
6 天
Sandoz Report: A Unified Approach to Overcoming Drug Shortages
A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% ...
centerforbiosimilars
8 天
Biosimilar Rituximab Safe, Effective for SLE After Switching
A study found that switching from rituximab to biosimilar CT-P10 is safe and effective for patients with systemic lupus ...
centerforbiosimilars
12 天
The Top 5 Biosimilar Articles for the Week of September 30
Number 3: Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while ...
centerforbiosimilars
11 天
Treatment Persistence, Safety After Switching to Infliximab Biosimilars in Canadians With IBD
A retrospective study of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment ...
centerforbiosimilars
7 天
Duke Publishes Recommendations for Developing CGT Biosimilars
Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex ...
centerforbiosimilars
16 天
Fourth Ustekinumab Biosimilar, Otulfi, Approved in US
Otulfi was approved simultaneously in the European Union. In the US, it will launch in February 2025.
centerforbiosimilars
3 天
From Skepticism to Success: Insights Into Biosimilar Market Acceptance
Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center, discusses the potential of biosimilars and challenges in the ...
centerforbiosimilars
10 天
Biosimilars Policy Roundup for September 2024—Podcast Edition
On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which ...
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