Biosimilar: What it is not

British Journal of Clinical Pharmacology

Volumn 80, Issue 5, 2015, Pages 949-956

  De Mora, Fernando ^a  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

Author keywords

biobetter; biologic; biosimilar; biotechnology derived medicine; generic; non original biologic

Indexed keywords

BIOSIMILAR AGENT;

ARTICLE; AWARENESS; BIOEQUIVALENCE; BIOLOGICAL ACTIVITY; EUROPEAN MEDICINES AGENCY; EVIDENCE BASED MEDICINE; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; HUMAN; IMMUNOGENICITY; PRIORITY JOURNAL; DRUG APPROVAL; STANDARDS;

BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; HUMANS;

EID: 84946495021     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12656     Document Type: Article

References (40)

1. European Commission Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council, on the Community code relating to medicinal products for human use. 25 June 2003.
2. EMA. Guideline on similar biological medicinal products. CHMP/437/04. 30 October 2005.
3. Section 351(k) of the Public Health Service Act as amended by the Patient Protection and Affordable Care Act under the Biologics Price Competition and Innovation (BPCI) Act (USA). 10 March 2010.
4. Guideline on similar biological medicinal products. CHMP/437/04 Rev 1. 23 October 2014.
5. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, Gravanis I, Heim HK, Heinonen E, Ho K, Moreau A, Narayanan G, Kruse NA, Reichmann G, Thorpe R, van Aerts L, Vleminckx C, Wadhwa M, Schneider CK,. Biosimilars: what clinicians should know. Blood 2012; 120: 5111-7.
6. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Heim HK, Heinonen E, Ho K, Narayanan G, Thorpe R, Vleminckx C, Wadhwa M, Schneider CK,. Biosimilars-why terminology matters. Nature Biotechnology 2011; 29: 690-3.
7. Rickwood S, &, Di Biase S, (IMS Health Report). Searching for Terra Firma in the Biosimilars and Non-Original Biologics Market, 2013. https://www.imshealth.com/deployedfiles/imshealth/Global/Content/Healthcare/Life%20Sciences%20Solutions/Generics/IMSH-Biosimilars-WP.pdf (last accessed 30 April 2015).
8. Dylst P, Vulto A, Simoens S,. Barriers to the uptake of biosimilars and possible solutions: A Belgian case study. Pharmacoeconomics 2014; 32: 681-91.
9. GfK Report. Factors Supporting a Sustainable European Biosimilar Medicines Market. September 2014. http://www.egagenerics.com/images/Website/GfK-Final-Report-Factors-Supporting-a-Sustainable-European-Biosimilar-Medicines-Market.pdf (last accessed 30 April 2015).
10. Ivo A,. Cost savings from anemia management with v2biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries. Future Oncol 2014; 10: 1599-609.
11. Haustein R, de Millas C, Höer A, Haüssler B,. Saving money in the European healthcare systems with biosimilars Generics and Biosimilars Initiative Journal (GaBI Journal) 2012; 1: 120-6.
12. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (draft guideline) EMEA/CHMP/BMWP/42832/2005 Rev. 1, 2013.
13. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) EMA/CHMP/BWP/247713/2012, December 2014.
14. Nation RL, &, Sansom LN,. Bioequivalence requirements for generic products. Pharmacol Ther 1994; 62: 41-55.
15. Smit Sibinga CT,. Small-pool high-yield factor VIII production. Crit Rev Clin Lab Sci 1986; 24: 43-70.
16. Jiang R, Monroe T, McRogers, R, Larson PJ,. Manufacturing challenges in the commercial production of recombinant coagulation factor VIII. Haemophilia 2002; 8: 1-5.
17. Schiestl, M., Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011; 29: 310-2.
18. Sharma, B., Immunogenicity of therapeutic proteins. Part 3: Impact of manufacturing changes. Biotech Adv 2007; 25: 325-31.
19. EMA. Comparability of biotechnology-derived medicinal products after a change in the manufacturing process-non-clinical and clinical issues. EMEA/CHMP/BMWP/101695/2006, 2007.
20. EMA. Assessment report for Aranesp. (Procedure No. EMEA/H/C/332/X/0042). EMEA/478499/2008). July 2008.
21. Warren, JB,. Generics, chemisimilars and biosimilars: is clinical testing fit for purpose? Br J Clin Pharmacol 2013; 75: 7-14.
22. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK,. Biosimilars: the science of extrapolation. Blood 2014; 124: 3191-6.
23. Donghua Y, Barker KB, Li RF, Meng X, Reich SD, Ricart AD, Rudin D, Taylor CT, Zacharchuk CM, Hansson AG,. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (Reflections B327-01). Br J Clin Pharmacol 2014; 78: 1281-90.
24. Grabowski H, Henry G, Guha R, Salgado M,. Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future. Health affairs (Project Hope) 2014; 33: 1048-57.
25. Schenck R,. Biologicals and biosimilars: One and the same? Abstracts of papers of the American Chemical Society. 240, Meeting Abstract: 87-CINF, August 2010.
26. Phinney, K., Analysis of biological therapeutic agents and biosimilars. Anal Bioanal Chem 2014; 406: 6539.
27. Ramanan S, &, Grampp G,. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs: clinical immunotherapeutics biopharmaceuticals and gene therapy 2014; 28: 363-72.
28. Casadevall N, Mayeux P, Kiladjian JJ, Kolta A, Martin-Dupont P, Michaut P, Viron B, Varet B,. Antibodies against human erythropoietin inducing pure red cell aplasia (PRCA): Report of three cases. Blood, 94 (Supplement: 1): 50A-50A Part:1(Meeting Abstract: 211), 1999.
29. EMA. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. EMEA/CHMP/BMWP/14327/2006, 2007.
30. Beck A, Sanglier-Cianférani S, Van Dorsselaer A,. Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal Chem 2012; 84: 4637-46.
31. Iida S, Kuni-Kamochi R, Mori K, Misaka H, Inoue M, Okazaki A, Shitara K, Satoh Two mechanisms of the enhanced antibody-dependent cellular cytotoxicity (ADCC) efficacy of non-fucosylated therapeutic antibodies in human blood. BMC Cancer 2009 9: 58 doi: 10.1186/1471-2407-9-58.
32. EMA. Eporatio EPAR summary for the public. EMEA/540882/2009.
33. EMA. Guideline on Similar Biological Medicinal Products. CHMP/437/04 Rev 1, 2014.
34. Schellekens H,. Biosimilar epoetins: how similar are they? Eur J Hosp Pharma Sci 2004; 3: 43-7.
35. Meager A, Dolman C, Dilger P, Bird C, Giovannoni G, Schellekens H, Thorpe R, Wadhwa M,. An assessment of biological potency and molecular characteristics of different innovator and non-innovator Interferon-beta products. Journal of Interferon and Cytokine Research 2011; 31: 383-92.
36. Praditpornsilpa K, Tiranathanagul K, Kupatawintu P, Jootar S, Intragumtornchai T, Tungsanga K, Teerapornlertratt T, Lumlertkul D, Townamchai N, Susantitaphong P, Kataveting P, Kanjanabuch T, Avihingsanon Y, Eiam-Ong S,. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int 2011; 80: 88-92.
37. Mohammad Amir S, Behrouz V, Shiva S, Ali Amini H, Joel O,. Neutralizing antibodies in multiple sclerosis patients on weekly intrasmuscular Avonex and biosimilar interferon beta-1 (CinnoVVex): comparing results of measurements in two different laboratories. J Imm Met 2013; 388: 46-8.
38. EMA. Assessment report Remsima EPAR. EMA/CHMP/589317/2013.
39. Schneider CK, Borg JJ, Ehmann F, Ekman, N, Heinonen E, Ho K, Hoefnagel MH, van der Plas RM, Ruiz S, van der Stappen AJ, Thorpe R, Tiitso K, Tsiftsoglou AS, Vleminckx C, Waxenecker G, Welin M, Weise M, Trouvin JH,. In support of the European Union biosimilar framework. Nat Biotechnol 2012; 30: 745-8.
40. Concept paper on the development of a committee for proprietary medicinal products (CPMP) guideline on comparability of biotechnology-derived products, CPMP/BWP/1113/1998.