An Introduction to Biologics and Biosimilars. Part I: Biologics: What are They and Where Do They Come from?

Ropp KL . Just what is a biologic, anyway? FDA Consumer 1993;27 (3).

Covic A Kuhlmann M . Biosimilars: recent developments. Int Urol Nephrol 2007;39 (1):261–6.

Protein Data Bank. A resource for studying biological macromolecules. Available: www.pdb.org/pdb/home/home.do (accessed May 4, 2009).

Waldman TA . Immunotherapy: past, present and future. Nat Med. 2003;9 (3):269–77.

Plotkin SA . Vaccines: past, present and future. Nat Med. 2005;11 Supp 4:S5–11.

Gricks C Cann CI Merrin A . Antibody therapies in oncology. Waltham (MA): Decision Resources, Inc.; Jun 2008.

Westphal NJ Malecki MJ . Biosimilars 2007–2017: shifting payer and physician opinion increases the hurdles to uptake. Waltham (MA): Decision Resources, Inc.; 2008.

Biotechnology Institute Historical events in biotechnology. Available: www.biotechinstitute.org/what_is/timeline.html (accessed May 2, 2009).

Nobelprize.org. Emil von Behring: the founder of serum therapy. 2001 Dec 3. Available: http://nobelprize.org/nobel_prizes/medicine/articles/behring/index.html (accessed May 11, 2009).

Glassman RH Sun AY . Biotechnology: identifying advances from the hype. Nat Rev Drug Discov 2004;3 (2):177–83.

Sneader W . History of insulin. Encyclopedia of life sciences. 2001 April 25. Available: http://mrw.interscience.wiley.com/emrw/9780470015902/els/article/a0003623/current/abstract?hd=All,w&hd=All,sneader (accessed March 11, 2010).

Rosenfeld L . Insulin: discovery and controversy. Clin Chem 2002;48 (12):2270–88.

Strettona AO . The first sequence: Fred Sanger and insulin. Genetics 2002;162 (2):527–32.

Cohen SN Chang AC Boyer HW Helling RB . Construction of biologically functional bacterial plasmids in vitro. Proc Natl Acad Sci USA 1973;70 (11):3240–4.

Goeddel DV Levinson AD . Obituary: Robert A. Swanson (1947-99). Nature 2000;403 (6767):264.

Abate T . The birth of biotech: how the germ of an idea became the genius of Genentech. San Francisco Chronicle. 2001 April 1. Available: http://articles.sfgate.com/2001-04-01/business/17593472_1_herb-boyer-genentech-s-south-san-fran-cisco-bay-area (accessed April 23, 2009).

Eli Lilly & Company Annual report. Indianapolis (IN): Eli Lilly & Company; 2008.

Jelkmann W . Erythropoietin after a century of research: younger than ever. Eur J Haematol 2007;78 (3):183–205.

Miyake T Kung CK Goldwasser E . Purification of human erythropoietin. J Biol Chem 1977;252 (15):5558–64.

Dordal MS Wang FF Goldwasser E . The role of carbohydrate in erythropoietin action. Endocrinology 1985;116 (6):2293–9.

Smith S . Ten years of Orthoclone OKT3 (muromonab-CD3): a review. J Transpl Coord 1996;6 (3):109–19.

Kaufmann SH . Immunology's foundation: the 100-year anniversary of the Nobel Prize to Paul Ehrlich and Elie Metch-nikoff. Nat Immunol 2008;9 (7):705–12.

Steiner LA . Rodney Robert Porter (1917-1985). Nature 1985;317 (6036):383.

Köhler G Milstein C . Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975;256 (5517):495–7.

Ezzell C . Magic bullets fly again. Sci Am 2001;285 (4):34–41.

Goldsmith SJ . Radioimmunotherapy of lymphoma: Bexxar and Zevalin. Semin Nucl Med. 2010;40 (2):122–35.

Manoukian G Hagemeister F . Denileukin diftitox: a novel immunotoxin. Expert Opin Biol Ther 2009;9 (11):1445–51.