An Introduction to Biologics and Biosimilars. Part II: Subsequent Entry Biologics: Biosame or Biodifferent?

Shacter E . Quantification and significance of protein oxidation in biological samples. Drug Metab Rev 2000;32(3–4):307–26.

Robinson N . Protein deamidation. Proc Natl Acad Sci USA 2002;8(99):5283–8.

Rademacher W Parekh B Dwek A . Glycobiology. Annu Rev Biochem 1988;57:785–838.

Schachter H . The ‘yellow brick road’ to branched complex N-glycans. Glycobiology 1991;1(5):453–61.

Sharma B . Immunogenicity of therapeutic proteins. Part 3: Impact of manufacturing changes. Biotechnol Advances 2007;3(25):325–31.

Casadevall N Eckardt K Rossert J . Epoetin-induced autoimmune pure red cell aplasia. J Am Soc Nephrol 2005;16(1 Suppl):S67–9.

Schellekens H . Biosimilar epoetins: How similar are they? Eur J Hosp Pharm Sci 2004;3:43–7.

Schellekens H . Manufacture and quality control of biophar-maceuticals. Available: www.economiadelasalud.com/ediciones/66/08_pdf/manufacture.pdf (accessed August 4, 2009).

Sadamoto R Nishimura S . Glycosylation engineering of glycoproteins. Japan: Springer Berlin Heidelberg; 2008.

Emerging health care issues: follow-on biologics drug competition. Federal Trade Commission Report, 2009. Available: www.ftc.gov/os/2009/06/P083901biologicsreport.pdf (accessed March 15, 2010).

Health Canada. Fact sheet: subsequent entry biologics. Available: www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/fs-fi/fs-fi_seb-pbu_07-2006-eng.php (accessed January 4, 2010).

European Medicines Agency. Guideline on similar biological medicinal products, 2005. Available: www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf (accessed August 4, 2009).

Health Canada. Information and submission requirements for subsequent entry biologics (SEBs) and related documents, 2010. Available: www.hc-sc.gc.ca/dhp-mps/brgtherap/applicdemande/guides/seb-pbu/notice-avis_seb-pbu_2010-eng.php (accessed June 30, 2010).

European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues, 2006. Available: www.emea.europa.eu/pdfs/human/biosimilar/4934805en.pdf (accessed June 3, 2009).

US Food and Drug Administration. Omnitrope (somatropin) [rDNA origin]: questions and answers, 2006. Available: www.fda.gov/cder/drug/infopage/somatropin/qa.htm (accessed June 3, 2009).

European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, 2006. Available: www.emea.eu.int/pdfs/human/biosimilar/4283205en.pdf (accessed June 3, 2009).

European Medicines Agency. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, 2007. Available: www.emea.europa.eu/pdfs/human/biosimilar/1432706enfin.pdf (accessed June 3, 2009).

European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance on similar medicinal products containing somatropin, 2006. Available: www.emea.europa.eu/pdfs/human/biosimilar/9452805en.pdf (accessed June 3, 2009).

European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant human insulin, 2006. Available: www.emea.europa.eu/pdfs/human/biosimilar/3277505en.pdf (accessed June 3, 2009).

European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant erythropoietins, 2006. Available: www.emea.europa.eu/pdfs/human/biosimilar/9452605en.pdf (accessed June 3, 2009).

European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant granulocyte colony stimulating factor (G-CSF), 2006. Available: www.emea.europa.eu/pdfs/human/biosimilar/3132905en.pdf (accessed June 3, 2009).

European Medicines Agency. Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies. Available: www.ema.europa.eu/pdfs/human/biosimilar/63261309en.pdf (accessed January 10, 2010).

BIOTECanada. SEBs, biosimilars, FOBs: understanding the clinical implications and international experience. Available: www.biotech.ca/uploads/sebs/belin-110909.pdf (accessed December 10, 2009).

BIOTECanada. Principle for the safe introduction of subsequent-entry biologics (SEBs) into the Canadian healthcare system. Available: www.biotech.ca/uploads/sebs/biotecanada%20seb%20012308%20pdf.pdf (accessed December 20, 2009).

Zuñiga L Calvo B . Regulatory aspects of biosimilars in Europe. Trends Biotechnol 2009;7(27):385–7.

World Health Organization. Informal consultation on international non-proprietary names (INN) policy for biosimilar products, 2006. Available: www.who.int/medicines/services/inn/en/index.html (accessed June 3, 2009).

World Health Organization. General policies for monoclonal antibodies: INN working document 09.251. Available: www.who.int/medicines/services/inn/Generalpoliciesformonoclo-nalantibodies2009.pdf (accessed June 3, 2009).

Repchinsky C , editor. Compendium of Pharmaceuticals and Specialties. Ottawa (ON): Canadian Pharmacists Association; 2009.

European Medicine Agency. Refusal assessment report for Alpheon, 2006. Available: www.ema.europa.eu/humandocs/PDFs/EPAR/alpheon/H-585-RAR-en.pdf (accessed June 30, 2010).