The advent of biosimilar therapies in rheumatology-"O Brave New World"

Nature Reviews Rheumatology

Volumn 8, Issue 7, 2012, Pages 430-436

  Scheinberg, Morton A ^a   Kay, Jonathan ^b  

^a HOSPITAL ISRAELITA ALBERT EINSTEIN   (Brazil)

^b UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRHEUMATIC AGENT; AVENT; BI 695501; BI 6965501; BIOSIMILAR AGENT; CT P 10; CT P 13; ETANAR; ETANERCEPT; GP 2013; HD 203; KIKUZUBAM; LBEC 0101; MONOCLONAL ANTIBODY; PF 05280586; PRX 106; RITUXIMAB; TL 011; TUNEX; UNCLASSIFIED DRUG; YISAIPU;

AFRICA; ASIA; AUSTRALIA; COST CONTROL; DRUG APPROVAL; DRUG COST; DRUG DESIGN; DRUG EFFECT; DRUG EFFICACY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG MECHANISM; DRUG POTENCY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TARGETING; EUROPE; EXPERIMENTAL DESIGN; FOOD AND DRUG ADMINISTRATION; GEOGRAPHIC DISTRIBUTION; HUMAN; MEDICAL RESEARCH; NONHUMAN; NORTH AMERICA; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; RHEUMATIC DISEASE; RHEUMATOID ARTHRITIS;

ANTIRHEUMATIC AGENTS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG SUBSTITUTION; HUMANS; RHEUMATIC DISEASES; RHEUMATOLOGY; THERAPEUTIC EQUIVALENCY;

EID: 84863435547     PISSN: 17594790     EISSN: 17594804     Source Type: Journal    
DOI: 10.1038/nrrheum.2012.84     Document Type: Review

References (37)

1. Hyrich, K. L. et al. Outcomes after switching from one anti-tumor necrosis factor α agent to a second anti-tumor necrosis factor α agent in patients with rheumatoid arthritis: results from a large UK national cohort study. Arthritis Rheum. 56, 13-20 (2007).
2. Patent status information\register entry for European Patent 0343684. Intellectual Property Office [online] http://www.ipo.gov.uk/p-find-number? csbtype=F&csbpub =EP0343684 (2009).
3. Patent status information\register entry for European Patent 0409607 Intellectual Property Office [online]. http://www.ipo.gov.uk/p-find-number? csbtype=F&csbpub =EP0409607(2009).
4. US$54 billion worth of biosimilar patents expiring before 2020. Generics and Biosimilars Initiative Online [online]. http://www.gabionline. net/Biosimilars/Research/US-54-billion-worth-of-biosimilar-patents-expiring- before-2020(2011).
5. Medtrack [online], http://v1.medtrack.com/research/default.asp (2012).
6. Publications Office of the European Union. Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products. EUR-Lex [online]. http://eurlex.europa.eu/ LexUriServ/LexUriServ.do?u ri=CELEX:31992R1768:EN:HTML (1992).
7. Castanheira, L. G., Barbano, D. B. & Rech, N. Current development in regulation of similar biotherapeutic products in Brazil. Biologicals 39, 308-311 (2011).
8. Brockhaus, M. et al. Human TNF receptor fusion protein. US Patent 8,063,182 (1995).
9. Medco Health Solutions, Inc. Estimated dates of possible first time generic/Rx-to-OTC market entry. Medco [online], http://www. medcohealth.com/art/ corporate/anticipatedfirsttime-generics.pdf (2012).
10. Kay, J. Biosimilars: a regulatory perspective from America. Ar thritis Res. Ther. 13, 112 (2011).
11. US Food and Drug Administration. Guidance for Industry. Biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. Department of Health & Human Services [online], http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM273001.pdf (2012).
12. Dranitsaris, G., Amir, E. & Dorward, K. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drugs 71, 1527-1536 (2011).
13. Woodcock, J. et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat. Rev. Drug Discov. 6, 437-442 (2007).
14. McCamish, M. & Woollett, G. Worldwide experience with biosimilar development. MAbs 3, 209-217 (2011).
15. Mellstedt, H., Niederwieser, D. & Ludwig, H. The challenge of biosimilars. Ann. Oncol. 19, 411-419 (2008).
16. Schiestl, M. et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat. Biotechnol. 29, 310-312 (2011)
17. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: comparability of biotechnological/biological products subject to changes in their manufacturing process Q5E. ICH harmonisation for better health [online], http://www.ich.org/fileadmin/Public-Web- Site/ICH-Products/Guidelines/ Quality/Q5E/Step4/Q5E-Guideline.pdf (2004)
18. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products. European Medicines Agency [online], http://www.emea.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500003517.pdf (2005)
19. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. European Medicines Agency [online], http://www.emea.europa.eu/docs/en-GB/document-library/Scientific- guideline/2009/09/WC500003920.pdf (2006).
20. Liang, C. & Wang, J. China's perspective on similar biotherapeutic products. Biologicals 39, 312-316 (2011).
21. Knezevic, I. & Griffiths, E. Biosimilars\global issues, national solutions. Biologicals 39, 252-255 (2011).
22. Schellekens, H. & Moors, E. Clinical comparability and European biosimilar regulations. Nat. Biotechnol. 28, 28-31 (2010)
23. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing monoclonal antibodies. Draft. European Medicines Agency [online], http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2010/11/WC500099361.pdf (2010)
24. Committee for Medicinal Products for Human Use. Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. European Medicines Agency [online], http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2011/10/WC500115611.pdf (2011).
25. Barosi, G. et al. Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation. Haematologica 96, 937-942 (2011).
26. US Food and Drug Administration. FDA HR 3590\686. Patient Protection and Affordable Care Act. Title VII\Improving access to innovative medical therapies. Subtitle A\Biologics price competition and innovation. Sec. 7002. Approval pathway for biosimilar biological products. US Department of Health & Human Services [online], http://www.gpo.gov/fdsys/pkg/BILLS-111hr3590eas/pdf/BILLS- 111hr3590eas.pdf (2010).
27. US Food and Drug Administration. Regulatory information. Sec. 505. [21 USC §355] New Drugs. US Department of Health & Human Services [online], http://www.fda.gov/RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm (2009).
28. Kozlowski, S., Woodcock, J., Midthun, K. & Sherman, R. B. Developing the nation's biosimilars program. N. Engl. J. Med. 365, 385-388 (2011).
29. Kessler, M., Goldsmith, D. & Schellekens, H. Immunogenicity of biopharmaceuticals. Nephrol. Dial. Transplant. 21 (Suppl. 5), v9-v12 (2006).
30. Health Canada Health Products and Food Branch. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs) Health Canada [online], http://www.hc-sc.gc.ca/dhp-mps/alt-formats/pdf/ brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf (2010).
31. World Health Organization Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). World Health Organization [online]. http://www.who.int/biologicals/areas/biological- therapeutics/BIOTHERAPEUTICS-FOR-WEB-22APRIL2010.pdf(2009).
32. Núñez, H. Y. et al. The regulatory framework for similar biotherapeutic products in Cuba. Biologicals 39, 317-320 (2011).
33. Jailing, D. Xian Janssen launches Remicade in China. PharmAsia News [online], http://fdcalerts.typepad.com/asia/2007/10/xian-janssen-la.html (2007).
34. Maity, S. et al. A non-innovator version of etanercept for treatment of arthritis. Biologicals. 39, 384-395 (2011).
35. Malhotra, H. Biosimilars and non-innovator biotherapeutics in India: an overview of the current situation. Biologicals 39, 321-324 (2011).
36. Dr Reddy's launches Rituxan generic. FDC alerts [online]. http://fdcalerts.typepad.com/asia/2007/05/dr-reddys-launc.html (2007).
37. BioXpress therapeutics biosimilar pipeline. bioXPRESS Therapeutics SA [online], http://www.bioxpress.com/pipeline/default.asp (2011).