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centerforbiosimilars
1 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
2 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
1 天
The Top 5 Biosimilar Articles for the Week of October 7
Number 4: In September 2024, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in the biosimilars landscape, coinciding with ongoing legal disputes ...
centerforbiosimilars
5 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
3 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
4 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
11 天
Biosimilar Policy Roundup—September 2024
In September 2024, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in ...
centerforbiosimilars
7 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
6 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 ...
centerforbiosimilars
12 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
8 天
Eye on Pharma: High-Strength Trastuzumab Biosimilar; Originator Coverage Removals; CHMP ...
The FDA approved a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some ...
centerforbiosimilars
13 天
Future Biosimilar Trends, Challenges, and Opportunities
Ivo Abraham, PhD, RN, University of Arizona Cancer Center, explains how biosimilars are becoming more accessible but face ...
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