Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars-Reference-Cited by-同舟云学术

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Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

Published:2012-06-29 Issue:7 Volume:11 Page:527-540
ISSN:1474-1776
Container-title:Nature Reviews Drug Discovery
language:en
Short-container-title:Nat Rev Drug Discov

Author:

Berkowitz Steven A.,Engen John R.,Mazzeo Jeffrey R.,Jones Graham B.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Link

http://www.nature.com/articles/nrd3746.pdf

Reference144 articles.

1. Walsh, G. Biopharmaceutical benchmarks 2010. Nature Biotech. 28, 917–924 (2010). This comprehensive survey on the biopharmaceutical marketplace, carried out every 4 years, offers an overview of the key trends in the industry and new biopharmaceutical approvals.

2. Lawrence, S. Billion dollar babies — biotech drugs as blockbusters. Nature Biotech. 25, 380–382 (2007).

3. Erickson, B. E. Untangling biosimilars. Chem. Eng. News 88, 25–27 (2010).

4. Woodcock, J. et al. The FDA's assessment of follow-on protein products: a historical perspective. Nature Rev. Drug Discov. 6, 437–442 (2007).

5. Kozlowski, S., Woodcock, J., Midthun, K. & Sherman, R. B. Developing the nation's biosimilars program. N. Engl. J. Med. 365, 385–388 (2011). References 4 and 5 are two papers that were written by regulators at the FDA; these two papers have summarized in a compact form the agency's historical perspective on biosimilars — a perspective that became mostly encapsulated by the draft guidelines that were later issued.

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