Biosimilars and Bioanalytical Methods -- 专题文献

专题：Biosimilars and Bioanalytical Methods

This cluster of papers focuses on the immunogenicity of biosimilar therapeutics, including the validation of bioanalytical methods for assessing immunogenicity, the impact of manufacturing changes on immunogenicity, and the clinical outcomes and safety of switching from reference biologics to biosimilars. The use of dried blood spots for bioanalysis and the regulatory considerations for biosimilars are also prominent topics within this cluster.

专题：Biosimilars and Bioanalytical Methods

最新文献

Efficacy and safety of duvakitug in patients with Crohn's disease (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial

Neoplasm Adverse Events Associated With Anti‐Type 2 Biologics: An FAERS Database Pharmacovigilance Analysis Study

Automatic for the people: an introduction to self-collected capillary blood testing

From tiers to truth – a biomarker-based framework for clinically relevant immunogenicity assessment

Breaking the therapeutic ceiling in inflammatory bowel disease: myth or reality?

The evolving global landscape of first-in-class oncology drug innovation

EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5

Trust and Acceptance of Biosimilar Medications among the General Population in Saudi Arabia: Cross-Sectional Study

979f EFFICACY AND SAFETY OF THE FIRST CO-ANTIBODY THERAPY, JNJ-78934804, IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE REFRACTORY TO SYSTEMIC THERAPIES

Five-year efficacy and safety of guselkumab for moderately to severely active Crohn’s disease: Results from the phase 2 GALAXI 1 trial

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