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Biosimilars: Current situation and future expectations

Published online by Cambridge University Press:  20 January 2017

Guillermina Forno  and
Eduardo Orti
Guillermina Forno
Affiliation:
Research and Development Zelltek S.A., Universidad Nacional del Litoral, Ciudad Universitaria (3000) Santa Fe, Argentina. E-mail:
Eduardo Orti
Affiliation:
Research and Development Zelltek S.A., Universidad Nacional del Litoral, Ciudad Universitaria (3000) Santa Fe, Argentina
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Abstract

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Type
Reports
Information
European Journal of Risk Regulation , Volume 3 , Issue 2 , June 2012 , pp. 213 - 218
Copyright
Copyright © Cambridge University Press 2012

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References

1 Chen, Bao-Lu, “CMC Issues and Regulatory Requirements for Biosimilars”, 5 Trends in Bio/Pharmaceutical Industry (2009), pp. 19 et sqq., at p. 19Google Scholar.

2 Simoens, Steven, “Biosimilar medzicines and cost-effectiveness”, 3 ClinicoEconomics and Outcomes Research (2011), pp. 29 et sqq., at p. 30CrossRefGoogle ScholarPubMed.

3 Williams, Brent R. and Shen, David Wenyan, “Current Considerations for Biosimilar Therapeutics”, 5 Trends in Bio/Pharmaceutical Industry (2009), pp. 8 et sqq., at p. 9Google Scholar.

4 Kresse, Georg-Burkhard, “Biosimilars – Science, status, and strategic perspective”, 72 European Journal of Pharmaceutics and Biopharmaceutics (2009), pp. 479 et sqq., at p. 479CrossRefGoogle ScholarPubMed.

5 Directives 2003/63/EC of the European Parliament and of the Council of 25 June 2003 and 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.

6 EMEA, 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. EMEA/CHMP/ BMWP/94528/2005, 2006.

7 EMEA, 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. EMEA/CHMP/BMWP/31329/2005, 2006.

8 EMEA, 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 soluble insulin. EMEA/CHMP/BMWP/32775/2005, 2006.

9 EMEA, 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. EMEA/CHMP/BMWP/301636/2008, 2010.

10 EMEA, Reflect ion paper: non-clinical and clinical development of similar medicinal products containing recombinant interferon alpha. EMEA/CHMP/BMWP/102046/2006, 2009.

11 EMEA, Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecularweight- heparins. EMEA/CHMP/BMWP/118264/2007, 2009.

12 Concept paper on similar biological product containing recombinant interferon beta. EMA/CHMP/BMWP/86572/2010. Deadline for comments: 11 June 2010.

13 Concept paper on similar biological product containing recombinant follicle stimulating hormone. EMA/CHMP/BMWP/94899/2010. Deadline for comments: 1 June 2010.

14 Guideline on similar biological medicinal products containing monoclonal antibodies (Draft). EMA/CHMP/BMWP/403543/2010. End of consultation: 31 May 2011.

15 EMA, “Scientific Discussion: marketing authorisation for Omnitrope (Sandoz GmbH)”, 2006, available on the Internet at: <http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000607/WC500043692.pdf> (last accessed on 16 April 2012).

16 European Generic Medicines Association, “Vision 2015: the EGA 's thoughts on how to improve the legal and regulatory framework for generic and biosimilar medicines ”, 2010, available on the Internet at: <http://www.egagenerics.com/doc/EGA_Vision_2015.pdf> (last accessed on 16 April 2012).

17 McCamish, Mark and Woollett, Gillian, “Worldwide experience with biosimilar development, 3 mAbs (2011) pp. 209 et sqq. at p. 211CrossRefGoogle ScholarPubMed.

18 EMEA, Refusal assessment report for Alpheon. International Nonproprietary Name: recombinant human interferon-alfa-2a. Procedure No. EMEA/H/C/000585, 2006.

19 EMEA, Press release. Marvel LifeSciences Ltd withdraws its marketing authorisation applications for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel. Doc. Ref. EMEA/2435/2008, 2008.

20 WHO, Expert Committee on Biological Standardization. Geneva, 19 to 23 October 2009, “Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)”, 2009, available on the Internet at: <http://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/Guidelines_Biotherapeutic_products_FINAL_HK_IK_12_June.pdf> (last accessed on 16 April 2012).

21 FDA, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”, 2012, available on the Internet at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf> (last accessed on 12 April 2012).

22 FDA, “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product”, 2012, available on the Internet at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf> (last accessed on 12 April 2012).

23 FDA, “Biosimilars: Questions and Answers Regarding Implementation of the Biologic Price Competition and Innovation Act of 2009”, 2012, available on the Internet at: < http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273001.pdf> (last accessed on 12 April 2012).

24 Kozlowski, Steven, Woodcock, Janet, Midthurn, Karen and Sherman, Rachel Behrman, “Developing the Nation's Biosimilars Program” 365 The New England Journal of Medicine (2011), pp. 385 et sqq., at p. 385CrossRefGoogle ScholarPubMed.

25 Schellekens, Huub and Bausch, James, “Biopharmaceutical molecules are not created equally” 268 The Pharmaceutical Journal (2002) pp. 300 et sqq., at p. 300Google Scholar.

26 Schellekens, Huub, “Biosimilar therapeutics -what do we need to consider?” 2 Nephrology Dialysis Transplantation (2009) pp. i27 et sqq., at p. i28Google Scholar.

27 Xie, Hongwei, Chakraborty, Asish, Ahn, Joomi et al., “Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies” 2 mAbs (2011) pp. 379 et sqq., at p. 379CrossRefGoogle Scholar.

28 Grass, Josephine, Pabst, Martin, Chang, Martina et al., “Analysis of recombinant human follicle –stimulating hormone (FSH) by mass spectrometric approaches” 400 Analytical Bioanalytical Chemistry (2011), pp. 2427 et sqq., at p. 2427CrossRefGoogle ScholarPubMed.

29 Schiestl, Martin, Stangler, Thomas, Torella, Claudia et al., “Acceptable changes in quality attributes of glycosylated biopharmaceuticas” 29 Nature Biotechnology (2011), pp. 310 et sqq. at p. 310CrossRefGoogle Scholar.

30 EMEA, ICH Topic Q5E Comparability of Biotechnological/Biological Products, CPMP/ICH/5721/03, June 2005, avalaible on the Internet at: <http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002805.pd> (last accessed on 16 April 2012).

31 FDA, “Demonstration of Comparability of Hu man Biological Products, Including Therapeutic Biotechnology-derived Products”, 2006, available on the Internet at: <http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122879.htm> (last accessed on 16 April 2012).

32 Sandoz, “ Global biosimilar leader Sandoz testifies for Novartis at FDA hearing on US biosimilar pathway”, 03 November 2010, available on the Internet at: <http://www.sandoz.com/media_center/news/2010/press_releases/2010_11_03_sandoz_testimony.html> (last accessed on 16 April 2012).

33 Wiatr, Claudia, “US Biosimilar Pathway Unlikely to be used. Developers will opt for a traditional BLA Filing”, 25 Biodrugs (2011) pp. 63 et sqq., at p. 63CrossRefGoogle ScholarPubMed.

34 Bonilla, Jacqueline Wright and Beaver, Nathan, “The New US Biosimilar Legislation, One Year Later”, 9 Bioprocess International (2011), pp. 22 et sqq., at p. 24.Google Scholar

35 Lewis Krauskopf and Bharghavi Nagaraju, “Pfizer to sell biosimilar insulins in Biocon deal”, 2010, available on the Internet at: <http://in.reuters.com/article/2010/10/18/idINIndia-52267720101018> (last accessed on 16 April 2012).

36 Merck, “Merck and PAREXEL Form Strategic Alliance Focused on Clinical Development of Biosimilar Candidates”, available on the Internet at: < http://www.merck.com/newsroom/news-releasearchive/corporate/2011_0112.html> (last accessed on 10 December 2011).