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centerforbiosimilars
11 小时
BioRationality: Developer-Led Biosimilar Education Unnecessary, FDA’s Got it Covered
Sarfaraz K. Niazi, PhD, provides an overview of the current biosimilar education material offered by the FDA, emphasizing ...
centerforbiosimilars
1 天
Addressing Hesitance in Biosimilar Adoption
Sophia Humphreys, PharmD, explains that expanding biosimilars into new therapeutic areas faces hesitance due to maintenance therapies, emphasizing the importance of education, and highlights factors ...
centerforbiosimilars
10 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
5 天
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
10 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 ...
centerforbiosimilars
7 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
12 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
8 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 ...
centerforbiosimilars
2 天
Lana Pine
Patient-Reported Outcomes Similar Between Adalimumab-adbm, Reference Product in VOLTAIRE-RA Study ...
centerforbiosimilars
2 天
Dinakaran Balasubramanian
Patient-Reported Outcomes Similar Between Adalimumab-adbm, Reference Product in VOLTAIRE-RA Study ...
centerforbiosimilars
14 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
13 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 ...
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