FDA Biosimilar Action Plan: could improving pharmacovigilance of biologics improve patient and physician confidence in biosimilars?
Author:
Affiliation:
1. Global Regulatory and R&D Policy, Amgen Inc, Thousand Oaks, CA, USA
Publisher
Informa UK Limited
Subject
Pharmacology (medical),General Medicine
Link
https://www.tandfonline.com/doi/pdf/10.1080/14740338.2020.1733966
Reference2 articles.
1. The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study
2. Rationale, Opportunities, and Reality of Biosimilar Medications
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