Biosimilars in IBD: Hope or expectation?

Gut

Volumn 62, Issue 6, 2013, Pages 803-807

  Gecse, Krisztina B ^a,b   Khanna, Reena ^c   Van Den Brink, Gijs R ^a   Ponsioen, Cyriel Y ^a   Löwenberg, Mark ^a   Jairath, Vipul ^d   Travis, Simon P L ^e   Sandborn, William J ^c,e   Feagan, Brian G ^c,f   D'Haens, Geert R A M ^a,b  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b European Division   (Netherlands)

^c ROBARTS RESEARCH INSTITUTE   (Canada)

^d JOHN RADCLIFFE HOSPITAL   (United Kingdom)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f UNIVERSITY OF WESTERN ONTARIO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; CT P 13; EP 2000; HUMAN GROWTH HORMONE; INFLIXIMAB; METHOTREXATE; MONOCLONAL ANTIBODY; PLD 108; RATIOEPO; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; REMSIMA; UNCLASSIFIED DRUG; XM 02;

ANEMIA; ANKYLOSING SPONDYLITIS; CHEMICAL MODIFICATION; CHRONIC INFLAMMATION; CHRONIC KIDNEY FAILURE; CLINICAL TRIAL (TOPIC); CROHN DISEASE; DRUG APPROVAL; DRUG CHOICE; DRUG COST; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG IDENTIFICATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG PURITY; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG STRUCTURE; DRUG SUBSTITUTION; DRUG SURVEILLANCE PROGRAM; ENTERITIS; FOOD AND DRUG ADMINISTRATION; GENETIC ENGINEERING; GROWTH HORMONE DEFICIENCY; HEALTH CARE ACCESS; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INFUSION RELATED REACTION; MALIGNANT NEOPLASTIC DISEASE; MOLECULAR INTERACTION; NEUTROPENIA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRADER WILLI SYNDROME; PRIORITY JOURNAL; PURE RED CELL ANEMIA; REVIEW; RHEUMATOID ARTHRITIS; SHORT STATURE; SMALL FOR DATE INFANT; TURNER SYNDROME; WORLD HEALTH ORGANIZATION;

BIOSIMILAR PHARMACEUTICALS; HUMANS; INFLAMMATORY BOWEL DISEASES; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 84876938678     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2012-303824     Document Type: Review

References (46)

1. European Medicines Agency. Biosimilar medicines. 2012. 14-11-2012.
2. Weise M, Bielsky MC, De SK, et al. Biosimilars: why terminology matters. Nat Biotechnol 2011;29:690-3.
3. European Medicines Agency. European Assessment Reports for authorised medicinal products for human use. 2012. 14-11-2012.
4. European Medicines Agency. Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use, November 2012. 2012. 14-11-2012.
5. Biosimilar News. World's first biosimilar antibody is approved in Korea. 2012. 14-11-2012.
6. Nature Medicine News. Biologic drugs set to top 2012 sales. Nat Med 2012;18:636.
7. Koelewijn C, Schrijvers A, Oldenburg B. Infliximab use in patients with Crohn's disease: quality of life, costs and resource use. Neth J Med 2006;64:212-18. (Pubitemid 44203650)
8. Blackstone EA, Fuhr JP Jr. Innovation and competition: will biosimilars succeed?: the creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety. Biotechnol Healthc 2012;9:24-7.
9. Braido F, Holgate S, Canonica GW. From "blockbusters" to "biosimilars": An opportunity for patients, medical specialists and health care providers. Pulm Pharmacol Ther 2012;25:483-6.
10. Jefferis R. Glycosylation as a strategy to improve antibody-based therapeutics. Nat Rev Drug Discov 2009;8:226-34.
11. Crommelin DJ, Storm G, Verrijk R, et al. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm 2003;266:3-16. (Pubitemid 37249303)
12. Misra M. Biosimilars: current perspectives and future implications. Indian J Pharmacol 2012;44:12-14.
13. Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29:310-12.
14. European Medicines Agency. Comparability of biotechnological/biological products subject to changes in their manufacturing process. 2005. 9-1-0013.
15. Beck A. Biosimilar, biobetter and next generation therapeutic antibodies. MAbs 2011;3:107-10.
16. World Health Organization. International nonproprietary names (INN) for biological and biotechnological substances. 2010.17-11-2012.
17. Weise M, Bielsky MC, De SK, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-7.
18. Jiang H, Wu SL, Karger BL, et al. Characterization of the glycosylation occupancy and the active site in the follow-on protein therapeutic: TNK-tissue plasminogen activator. Anal Chem 2010;82:6154-62.
19. Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm 2004;243-7.
20. Mody R, Goradia V, Gupta D. How similar are biosimilars in India? A blind comparative study. 2012. http://www.pharmafocusasia.com/research-development/ blind-comparative-study.html (accessed 7 Mar 2013).
21. Brinks V, Hawe A, Basmeleh AH, et al. Quality of original and biosimilar epoetin products. Pharm Res 2011;28:386-93.
22. Singh SK. Impact of product-related factors on immunogenicity of biotherapeutics. J Pharm Sci 2011;100:354-87.
23. Buttel IC, Chamberlain P, Chowers Y, et al. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals 2011;39:100-9.
24. Jahn EM, Schneider CK. How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations. N Biotechnol 2009;25:280-6.
25. McKoy JM, Stonecash RE, Cournoyer D, et al. Epoetin-associated pure red cell aplasia: past, present, and future considerations. Transfusion 2008;48:1754-62.
26. Boven K, Knight J, Bader F, et al. Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mystery. Nephrol Dial Transplant 2005;20(Suppl 3):iii33-40. (Pubitemid 40711827)
27. Haag-Weber M, Eckardt KU, Horl WH, et al. Safety, immunogenicity and ef ficacy of subcutaneous biosimilar epoetin-alpha (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study. Clin Nephrol 2012;77:8-17.
28. Seidl A, Hainzl O, Richter M, et al. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res 2012;29:1454-67.
29. Grimberg A, Feudtner C, Gordon CM. Consequences of brand switches during the course of pediatric growth hormone treatment. Endocr Pract 2012;18:307-16.
30. Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther 2012;12:1473-85.
31. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). 27-9-2012. 18-11-2012.
32. EMEA. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products. 2005. 1-11-2012.
33. European Medicines Agency. Similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. 2012. 30-11-2012.
34. Kozlowski S, Woodcock J, Midthun K, et al. Developing the nation's biosimilars program. N Engl J Med 2011;365:385-8.
35. Health Canada. Guidance For Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). 5-3-2010. 18-11-2012.
36. Kay J, Feagen B, Guirguis M, et al. National Summit on Subsequent Entry Biologics in Canada. Chairman's report. 2012. 20-11-2012.
37. U.S. Food and Drug Administration. Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009. 22-3-2012. 18-11-2012.
38. Mullard A. Can next-generation antibodies offset biosimilar competition? Nat Rev Drug Discov 2012;11:426-8.
39. Park W, Hrycaj P, Kovalenko V, et al. A randomized, double-blind, phase I study demonstrates equivalence in pharmacokinetics, safety, and efficacy of CT-P13 and infliximab in patients with ankylosing spondylitis. Ann Rheum Dis 2012;71(Suppl III).
40. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003;348:601-8. (Pubitemid 36204954)
41. Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology 2009;137:1628-40.
42. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010;362:1383-95.
43. Sandborn WJ, Hanauer SB, Katz S, et al. Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology 2001;121 :1088-94. (Pubitemid 33022088)
44. Sandborn WJ, Colombel JF, Sands BE, et al. Abatacept for Crohn' s disease and ulcerative colitis. Gastroenterology 2012;143 :62-9.
45. Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis 2007;13:1323-32. (Pubitemid 350206841)
46. Mody R, Varshney B, Patankar D. Understanding variations in biosimilars: correlation with risk and regulatory implications. Int J Risk Saf Med 2010;(22):27-40.