BioRationality—How to Promote Science to Secure Waiver of Comparative Efficacy Testing for Biosimilars
CenterForBiosimilars
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21h ago
Sarfaraz K. Niazi, PhD, makes suggestions for what arguments will help convince the FDA to waive clinical efficacy testing requirements for biosimilar approvals ..read more
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EHA Poster Shows Transfusion Avoidance Rates Were Comparable Between Eculizumab Biosimilar, Soliris
CenterForBiosimilars
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3d ago
A poster from the European Hematology Association’s 2024 annual meeting in Madrid, Spain, showed similar rates of transfusion avoidance between patients with paroxysmal nocturnal hemoglobinuria who were administered reference eculizumab (Soliris) and those administered an eculizumab biosimilar (SB12 ..read more
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The Top 5 Biosimilar Articles for the Week of June 10
CenterForBiosimilars
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3d ago
Here are the top 5 biosimilar articles for the week of June 10, 2024 ..read more
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Switch to Adalimumab Biosimilar Safe, Effective for Uveitis, but the Nocebo Effect Persists
CenterForBiosimilars
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4d ago
Switching patients with non-infectious uveitis from originator adalimumab to biosimilar adalimumab-atto was safe and effective, but some patients experienced the nocebo effect, where negative adverse events are caused by patients’ poor perception of the drug rather than the medication itself ..read more
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Real-World Study: Nonmedical Switch to Infliximab Biosimilar Is Safe, Effective in Pediatric Patients With IBD
CenterForBiosimilars
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5d ago
A real-world study of children and young adults with inflammatory bowel disease (IBD) switched from the infliximab reference product to a biosimilar concluded effectiveness was maintained over 12 months based on stable remission rates and biochemical markers ..read more
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New Data Shows Safety of Ado-Trastuzumab, Trastuzumab Biosimilars in HER2+ Cancers
CenterForBiosimilars
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1w ago
Posters from the American Society of Clinical Oncology annual meeting showcased safety and efficacy data for a trastuzumab biosimilar and an ado-trastuzumab biosimilar in HER2-positive (HER2+) cancers ..read more
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Review Finds 7 Themes That Can Help Define the Value of Biosimilars
CenterForBiosimilars
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1w ago
Authors of an integrated literature review identified 7 themes that help stakeholders define the value of biosimilar portfolios beyond cost savings, which could provide stakeholders better clarity as to the value of a biosimilar portfolio vs a single biosimilar within a portfolio ..read more
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Switching Patients With IBD to Infliximab, Adalimumab Biosimilars Did Not Impact Efficacy
CenterForBiosimilars
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1w ago
Researchers reviewed real-world evidence on the safety and effectiveness of switching from tumor necrosis factor-α inhibitor originators to biosimilars in inflammatory bowel disease (IBD), prompted by mandatory switching policies in most Canadian provinces ..read more
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The Top 5 Biosimilar Articles for the Week of June 3
CenterForBiosimilars
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1w ago
Here are the top 5 biosimilar articles for the week of June 3, 2024 ..read more
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Biosimilars Check-In: Application Acceptances, European Approvals, New Partnerships
CenterForBiosimilars
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1w ago
American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe ..read more
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