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Expert Opinion on Biological Therapy Volume 24, 2024 - Issue 7: Biosimilars 2024
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Original Research

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications – an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis

Heather Rae Hufnagela Infectious Disease Internal Medicine and Global Brands, Pfizer, Global Regulatory Science, Collegeville, PA, USACorrespondence[email protected]
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Scott D Tennysonb International Regulatory Science and Policy, Pfizer Global Regulatory Science, Peapack, NJ, USAView further author information
Pages 627-635 | Received 27 Mar 2024, Accepted 01 Jul 2024, Published online: 04 Jul 2024

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