A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006)
Author:
Affiliation:
1. Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA
2. Cancer Expert Now, Morristown, NJ, USA
3. Sandoz GmbH, Holzkirchen, Germany
Publisher
Informa UK Limited
Subject
General Medicine
Link
https://www.tandfonline.com/doi/pdf/10.1080/03007995.2022.2061707
Reference34 articles.
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2. US Food and Drug Administration. Biosimilar and interchangeable products. 2020. [cited 2021 Aug 16]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products.
3. Biosimilars: the science of extrapolation
4. Acceptable changes in quality attributes of glycosylated biopharmaceuticals
5. Batch-to-batch N-glycosylation study of infliximab, trastuzumab and bevacizumab, and stability study of bevacizumab
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