References
- Pharmaceutical Research and Manufacturers of America. Biotechnology Medicines in Development Report 2008; www.phrma.org/sites/phrma.org/files/attachments/Biotech%202008.pdf
- So AD, Katz SL. Biologics Boondoggle New York Times 2010; March 8
- DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0034:0057:EN:PDF
- European Public Assessment Report EMEA/H/C/607. Omnitrope (somatropin) www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000607/WC500043689.pdf
- Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER) April 1996 www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122879.htm
- Casadevall N. Immune-response and adverse reactions: PRCA case example http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2009/11/WC500011064.pdf
- Usdin S. Myozyme's zig zags. BioCentury 2008; 16:1 - 6
- EU Guideline on Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substances: Quality issues (CPMP December 2003) www.emea.europa.eu/pdfs/human/bwp/320700en.pdf
- ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. EU: Adopted by CMPM, December 1, 2004, CPMP/ICH/5721/03, date for coming into operation: June 2005; MHLW: Adopted 26 April 2005, PFSB/ELD Notification No. 0426001; FDA: Published in the Federal Register, Vol. 70, No. 125, June 30, 2005; 37861-37862 www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf
- Directive 2004/27/EC of the European Parliament and of The Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0034:0057:EN:PDF
- Senate HELP Full Committee Hearing “Follow-On Biologics” March 8, 2007 http://help.senate.gov/hearings/hearing/?id=0d7fdce8-b5cd-5a56-8930-31dfb58e7c11
- FDA Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products, 11/3/2010 Transcript Document ID: FDA-2010-N-0477-012 www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480bafe46
- Federal register notice Food and Drug Administration [Docket No. FDA-2010-N-0477] Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf
- Biologics Price Competition and Innovation Act (BPCIA) provisions of the Patient Protection and Affordable Care Act (PPACA) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h3590enr.txt.pdf
- Schellekens H. Biosimilar epoetins: How similar are they?. Eur J Hosp Pharm 2004; 10:243 - 247
- Brockmeyer C, Seidl A. Binocrit: assessment of quality, safety and efficacy of biopharmaceuticals. Eur J Hosp Pharm Prac 2009; 15:34 - 40
- European Generics Medicines Association. EGA Conference Highlights: 6th European Generics Medicines Association Biosimilars Symposium 2008 www.egagenerics.com/doc/ega_highlights_2008_02.pdf
- Novartis submission to FDA-2010-N-0477 docket on Notice: Approval Pathway for Biosimilar and Interchangeable Biological Products; Hearing www.regulations.gov/#!documentDetail;D=FDA-2010-N-0477-064.1
- Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. Statement of Janet Woodcock MD, Deputy Commissioner, Chief Medical Officer, Food and Drug Administration before the Subcommittee on Health, House Committee on Energy and Commerce May 2, 2007 www.fda.gov/NewsEvents/Testimony/ucm154017.htm
- Follow-on Protein Products. Statement of Janet Woodcock MD, Deputy Commissioner, Chief Medical Officer Food and Drug Administration before the House Committee on Oversight and Government Reform, March 26, 2007 www.fda.gov/NewsEvents/Testimony/ucm154070.htm
- FDA Guidance for Industry. Q8, Q9 and Q10 Questions and Answers www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM210822.pdf
- FDA response to the Citizen petitions of Pfizer, BIO and Genentech. Re: Dockets Nos. 2004P-0231/CP1 and SUP1, 2003P-0176/CP1 and EMC1, 2004P-0171/CP1 and 2004N-0355 www.fda.gov/ohrms/dockets/dockets/04P0231/04P-0231-pdn0001.pdf
- WHO Expert Committee on Biological Standardization, Geneva. Guidelines on evaluation of similar biotherapeutic products (SBPs) 2009; October 9 to 23 www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
- Beck A, Wurch T, Reichert JM. 6th European Antibody Congress 2010: November 29–December 1, 2010, Geneva, Switzerland. mAbs 2011; 3:111 - 134
- European Medicines Agency. Biosimilar guidelines www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002958c