What role for real-world evidence in market access of biosimilars?

Experience with the use of biosimilars in real-life practice provides an excellent opportunity to collect real-world evidence aimed at addressing residual uncertainties about biosimilars. Hence, this aims to explore the role of real-world evidence on biosimilars by showcasing how real-world evidence studies have contributed to addressing key questions affecting biosimilar market access. We find that the comparable efficacy and safety of a biosimilar and the reference product is corroborated by real-world evidence.

Patient characteristics and use for bevacizumab in ophthalmology and oncology in a distributed research network.

Background: Although bevacizumab and its biosimilars are commonly used, there are limited real-world data on bevacizumab use in the United States, especially biosimilar bevacizumab used in ophthalmologic conditions.

Objective: To evaluate use patterns and patient characteristics for the originator bevacizumab relative to its biosimilars for labeled and off-label oncology and ophthalmology conditions and characterize adverse events in patients using bevacizumab for oncologic indications.

Methods: We conducted a retrospective cohort study with the Biologics and Biosimilars Collective Intelligence Consortium-distributed database to identify patients aged 21 years and older who received bevacizumab between January 1, 2010, and June 30, 2021.

Structural Analysis of Amylin and Amyloid β Peptide Signaling in Alzheimer's Disease.

Amylin and amyloid β belong to the same protein family and activate the same receptors. Amyloid β levels are elevated in Alzheimer's disease. Recent studies have demonstrated that amylin-based peptides can reduce the symptoms of Alzheimer's disease in animal models.