The Basics
The Power of Biologics
  1. U.S. Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed December 21, 2014.
  2. Amgen Inc. Amgen 2004 Annual Report. http://library.corporate-ir.net/library/61/616/61656/items/143940/amgn2004AR.pdf. Accessed December 21, 2014.
  3. Pharmaceutical Research and Manufactures of America. Discoverers 2011 Award. 2011. http://www.phrma.org/sites/default/files/pdf/11-038_phrma_discaw2011b_0401.pdf. Accessed December 21, 2014.
  4. Generics and Biosimilars Initiative (GaBI). Small molecule versus biological drugs. http://www.gabionline.net/Biosimilars/Research/Small-molecule-versus-biological-drugs. Posted June 29, 2012. Accessed December 21, 2014.
  5. Biotechnology Industry Organization. How do drugs and biologics differ? http://www.bio.org/articles/how-do-drugs-and-biologics-differ. Posted November 10, 2010. Accessed December 21, 2014.
  6. Chaudhari P. The Impact of Rheumatoid Arthritis And Biologics on Employers and Payers. Biotechnol Healthc. 2008;5(2):PMC2706169. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2706169/. Accessed December 21, 2014.
What are Biosimilars?
  1. European Medicines Agency. Guideline on Similar Biological Medicinal Products [draft]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf. Draft overarching guidelines on biosimilars (reference number CHMP/437/04 Rev 1). Published May 22, 2013. Accessed December 21, 2014.
  2. Mellstedt, H., et. al. The challenge of biosimilars. Annals of Oncology 19. March 2008, pp. 411-419.
  3. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf. Published September 27, 2012. Accessed December 21, 2014.
  4. U.S. Food and Drug Administration. Guidance for industry: Quality considerations in demonstrating biosimilarity to a reference protein product. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf. Accessed December 21, 2014.
  5. World Health Organization. Expert Committee on Biological Standardization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.  Published October 23, 2009.   Accessed December 21, 2014
Biosimilars versus Generics:
  1. U.S. Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed December 21, 2014.
  2. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf. Published September 27, 2012. Accessed December 21, 2014.
  3. U.S. Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed December 21, 2014.
  4. Chow S-C. Biosimilars–Design and analysis of follow-on biologics. Boca Raton, FL: Chapman and Hall/CRC; 2012. Page 315.
  5. Id.
Intended Biosimilars:
  1. Praditpornsilpa K, Tiranathanagul K, Kupatawintu P, et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int. 2011;80(1):88-92. Available at: http://www.nature.com/ki/journal/v80/n1/full/ki201168a.html. Accessed December 21, 2014.
  2. Id.
How Biosimilars are Approved:
  1. FDA releases new guidance for biosimilar applications [news release]. Washington, DC: Sterne, Kessler, Goldstein & Fox P.L.L.C.; May 14, 2014. http://documents.jdsupra.com/ad106b59-6d21-4abb-ace9-4bd57bbc9310.pdf. Accessed December 21, 2014.
  2. Shapiro M. Two approaches to achieve biosimilarity. In: Quality considerations for biosimilars [slide 4]. Presented at: Biosimilars – An update, FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; August 8, 2012; Silver Spring, MD.
    http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM315764.pdf. Page 5.
The Safety of Biosimilars:
  1. U.S. Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed December 21, 2014.
  2. World Health Organization. Essential medicines and health products: International nonproprietary names. http://www.who.int/medicines/services/inn/en/. Accessed December 11, 2014.
  3. European Biopharmaceuticals Enterprises. EFPIA Position Paper, Naming of Biosimilar Medicinal Products: Options for Addressing Unique Safety Concerns. European Biopharmaceuticals Enterprises. [Online] July 2006. http://www.ebe-biopharma.eu/uploads/Modules/Documents/ebe-position-paper-labelling_3-07-2013.pdf.  Accessed on December 21, 2014.
  4. Pitts PJ. Biosimilar nomenclature: Can we achieve the truth, the whole truth, & nothing but the truth? Food and Drug Law Institute Food and Drug Policy Forum. 2014;4(8). Available at: https://www.cmpi.org/uploads/File/8-Pitts-2014.pdf. Accessed December 11, 2014.
  5. U.S. Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed December 21, 2014.
  6. Response to FDA implementation of the Biologics Price Competition and Innovation Act (BPCIA) by a group of specialty physician societies and members of AfPA’s National Physicians Biologics Working Group [letter]. August 14, 2014. http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2014/08/Updated-Biosimilars-Naming-Letter-from-Biologics-Prescribers-8-20-14.pdf. Accessed December 11, 2014.
  7. Id.
The Use of Biosimilars:
  1. Usdin S. Pathway to interchangeability: FDA’s Woodcock lays out path for biosimilars to be interchangeable [interview with FDA’s Janet Woodcock, Center for Drug Evaluation and Reasearch (CDER)]. BioCentury on Business. October 13, 2014. http://www.biocentury.com/biotech-pharma-news/regulation/2014-10-13/fdas-woodcock-lays-out-path-for-biosimilars-to-be-interchangeable-a11. Accessed December 21, 2014.
  2. U.S. Food and Drug Administration. Guidance for industry: Quality considerations in demonstrating biosimilarity to a reference protein product. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf. Accessed December 21, 2014.

The Promise of Biosimilars:

    1. Wu N. Cost of biologics per treated patient across immune-mediated inflammatory disease indications in a pharmacy benefit management setting: a retrospective cohort study. Clinical Therapeutics.2014;36(8). Available at: http://www.ncbi.nlm.nih.gov/pubmed/25062652 Accessed June 4, 2015.

Manufacturing
How a Biologic is Made
  1. U.S. Food and Drug Administration. Guidelines for industry: Biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. 2012. http://www.fda.gov/downloads/Drugs/Guidances/UCM273001.pdf. Accessed December 21, 2014.
  2. Id.
  3. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411-419.
Quality Processes for Medicines
  1. Amgen Continues Manufacturing Expansion with Additional $1 Billion Investment in Puerto Rico [press release]. Thousand Oaks, CA: Amgen (Business Wire); February 2, 2006. http://www.amgen.com/media/media_pr_detail.jsp?year=2006&releaseID=812284. Accessed December 21, 2014.
  2. Herman AC, Boone TC, Lu HS. Characterization, formulation, and stability of Neupogen (Filgrastim), a recombinant human granulocyte-colony stimulating factor. Pharm Biotech 1996;9:303-328.
  3. Amgen to Make Significant Investment in Manufacturing, R&D and Commercial Operations Expansion [press release]. Thousand Oaks, CA: Amgen (Business Wire); January 24, 2006. http://www.amgen.com/media/media_pr_detail.jsp?releaseID=807506. Accessed December 21, 2014.
  4. Jameel F, Khan MA. Quality by design as applied to the development and manufacturing of a lyophilized protein product. Am Pharm Rev. 2009;12(Nov):20-24. http://www.americanpharmaceuticalreview.com/Featured-Articles/117782-Quality-by-Design-as-Applied-to-the-Development-and-Manufacturing-of-a-Lyophilized-Protein-Product/. Accessed December 21, 2014.
  5. Id.
Reliability of Supply for Patients:
  1. Woodcock J, Wosinska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther. 2013;93(2):170-176. Available at: http://www.nature.com/clpt/journal/v93/n2/full/clpt2012220a.html. Accessed December 21, 2014.
  2. Id.
  3. Kaakeh R, Sweet BV, Reilly C, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm. 2011;68(19):1811-1819.
  4. Ventola CL. The drug shortage crisis in the United States: causes, impact and management strategies. P T. 2011;36(11):741-757.
  5. U.S. Food and Drug Administration. A review of FDA’s approach to medical product shortages (October 31, 2011). http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM277755.pdf. Accessed December 21, 2014.
  6. Mica A, Green L. Drug Availability: Considerations for the Hospital Pharmacist. Poster presented at: 2012 Summer Meting & Exhibition of the American Society of Health-System Pharmacists; June 9-13, 2012; Baltimore, MD.
  7. Mica A, Green L. Drug Availability: Considerations for the Hospital Pharmacist. Poster presented at: 2012 Summer Meting & Exhibition of the American Society of Health-System Pharmacists; June 9-13, 2012; Baltimore, MD.
Resources
Glossary
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  2. Bioassay. Wikipedia. http://en.wikipedia.org/wiki/bioassay. Accessed December 21, 2014.
  3. World Health Organization. Biological Qualifier: An INN Proposal. Programme on International Nonproprietary Names (INN). http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf?ua=1. July 2014. Accessed December 21, 2014.  
  4. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Adopted at: 60th Meeting of the WHO Expert Committee on Biological Standardization, Geneva, 19-23 October 2009. Accessed December 21, 2014.
  5. European Medicines Agency. Guideline on Similar Biological Medicinal Products [draft]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf. Draft overarching guidelines on biosimilars (reference number CHMP/437/04 Rev 1). Published May 22, 2013. Accessed December 21, 2014.
  6. U.S. Food and Drug Administration. Guidance for industry: Quality considerations in demonstrating biosimilarity to a reference protein product. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf. Accessed December 21, 2014.
  7. European Commission. Commission Implementing Regulation (EU) No 520/2012. Official Journal of the European Union. 2012, Vol. L159. http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1419026130454&uri=CELEX:32012R0520.  Accessed December 21, 2014.
  8. Chemical synthesis. Biology-Online Dictionary. Available at: http://www.biology online.org/dictionary/Chemical_synthesis.
  9. Chromatography. Merriam-Webster. Available at: http://www.merriamwebster.com/dictionary/chromatography.
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  12. Erythropoiesis-Stimulating Agents (ESAs). Blue Cross of Idaho. 2004. Available at: https://www.bcidaho.com/providers/medical_policies/pd/mp_50104.asp. Accessed December 21, 2014.
  13. glycans. IUPAC Gold Book -. Available at: http://goldbook.iupac.org/g02645.html. Accessed December 21, 2014.
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