메뉴 건너뛰기




Volumn 9, Issue 4, 2012, Pages 187-206

Overview of the biosimilars: Strategic considerations of various issues

Author keywords

Biosimilar; Extrapolation; Immunogenicity; Market access; Pipeline

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALEMTUZUMAB; ALPHA INTERFERON; ANTINEOPLASTIC AGENT; AZATHIOPRINE; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; CETUXIMAB; CLOTINAB; DENOSUMAB; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ERYTHROPOIETIN; ETANERCEPT; GENERIC DRUG; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; HUMAN GROWTH HORMONE; INFLIXIMAB; INTERFERON; METHOTREXATE; MONOCLONAL ANTIBODY; OMALIZUMAB; PALIVIZUMAB; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; STEROID; TRASTUZUMAB; TUMOR NECROSIS FACTOR INHIBITOR; UNCLASSIFIED DRUG; UNINDEXED DRUG; YI BI AO; YI SAI PU;

EID: 84877881506     PISSN: 17411343     EISSN: 17417090     Source Type: Journal    
DOI: 10.1177/1741134312470444     Document Type: Review
Times cited : (3)

References (30)
  • 3
    • 84877901045 scopus 로고    scopus 로고
    • SCRIP Business Insights. Report no. BI00050-010, December
    • SCRIP Business Insights. Strategies for entering the biosimilars market. Report no. BI00050-010, December 2011.
    • (2011) Strategies for Entering the Biosimilars Market
  • 5
    • 69449083908 scopus 로고    scopus 로고
    • Potential savings of biogenerics in the United States
    • accessed 13 August 2012
    • Miller S and Houts J. Potential savings of biogenerics in the United States. Express Scripts, http://www.expressscripts.com/industryresearch/ outcomes/onlinepublications/study/potentialSavingsBiogenericsUS.pdf (2007, accessed 13 August 2012).
    • (2007) Express Scripts
    • Miller, S.1    Houts, J.2
  • 6
    • 84877910387 scopus 로고    scopus 로고
    • accessed 13 August 2012
    • Ward M. Biosimilars move to centre stage, http://www.scripintelligence. com/home/comment/Biosimilars-move-to-centre-stage-305148 (2010, accessed 13 August 2012).
    • (2010) Biosimilars Move to Centre Stage
    • Ward, M.1
  • 7
    • 84877913361 scopus 로고    scopus 로고
    • Opportunities in the biosimilars market
    • Arnum PV. Opportunities in the biosimilars market. Pharmaceut Technol 2010; 34: 1-10.
    • (2010) Pharmaceut Technol , vol.34 , pp. 1-10
    • Arnum, P.V.1
  • 8
    • 70349512283 scopus 로고    scopus 로고
    • Incidence and clinical significance of immunogenicity to infliximab in Crohn's disease: A critical systematic review
    • Cassinotti A and Travis S. Incidence and clinical significance of immunogenicity to infliximab in Crohn's disease: A critical systematic review. Inflamm Bowel Dis 2009; 15: 1264-1275.
    • (2009) Inflamm Bowel Dis , vol.15 , pp. 1264-1275
    • Cassinotti, A.1    Travis, S.2
  • 9
    • 39449085441 scopus 로고    scopus 로고
    • Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: An open randomised trial
    • Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club
    • D'Haens G, Baert F, van Assche G, et al. Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet 2008; 371: 660-667.
    • (2008) Lancet , vol.371 , pp. 660-667
    • D'Haens, G.1    Baert, F.2    Van Assche, G.3
  • 10
    • 59649124785 scopus 로고    scopus 로고
    • SONIC: A randomized, double blind, controlled trial comparing infliximab and infliximab plus azathioprine to azathioprine in patients with Crohn's disease naïve to immunomodulators and biologic therapy
    • Colombel JF, Rutgeerts P, Reinisch W, et al. SONIC: a randomized, double blind, controlled trial comparing infliximab and infliximab plus azathioprine to azathioprine in patients with Crohn's disease naïve to immunomodulators and biologic therapy. Gut 2008; 57(Suppl II): A1.
    • (2008) Gut , vol.57 , Issue.SUPPL. II
    • Colombel, J.F.1    Rutgeerts, P.2    Reinisch, W.3
  • 11
    • 53049083113 scopus 로고    scopus 로고
    • A randomized, placebo-controlled study to evaluate the efficacy of infliximab in combination with methotrexate for the long-term treatment of Crohn's disease
    • Abstract 682C
    • Feagan B, MacDonald JWD, Panaccione R, et al. A randomized, placebo-controlled study to evaluate the efficacy of infliximab in combination with methotrexate for the long-term treatment of Crohn's disease. Gastroenterology 2008; 134(4 Suppl 1): Abstract 682C.
    • (2008) Gastroenterology , vol.134 , Issue.4 SUPPL. 1
    • Feagan, B.1    MacDonald, J.W.D.2    Panaccione, R.3
  • 12
    • 27744514865 scopus 로고    scopus 로고
    • Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): A randomized, controlled trial
    • Goekoop-Rueterman YPM, Vries-Bouwstra JK, Allart CF, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): A randomized, controlled trial. Arthritis Rheumat 2005; 52: 3381-3390.
    • (2005) Arthritis Rheumat , vol.52 , pp. 3381-3390
    • Goekoop-Rueterman, Y.P.M.1    Vries-Bouwstra, J.K.2    Allart, C.F.3
  • 13
    • 79955806071 scopus 로고    scopus 로고
    • Updated consenus statement on the use of rituximab in patients with rheumatoid arthritis
    • Buch MH, Smolen JS, Betteridge N, et al. Updated consenus statement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis 2011; 70: 909-920.
    • (2011) Ann Rheum Dis , vol.70 , pp. 909-920
    • Buch, M.H.1    Smolen, J.S.2    Betteridge, N.3
  • 14
    • 79957483535 scopus 로고    scopus 로고
    • American College of Rheumatology Recommendations for the treatment of juvenile idiopathic arthritis: Initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features
    • Beukelman T, Patkar NM, Saag KG, et al. American College of Rheumatology Recommendations for the treatment of juvenile idiopathic arthritis: Initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res 2011; 63: 465-482.
    • (2011) Arthritis Care Res , vol.63 , pp. 465-482
    • Beukelman, T.1    Patkar, N.M.2    Saag, K.G.3
  • 15
    • 75149161836 scopus 로고    scopus 로고
    • The second European evidence-based consensus on the diagnosis and management of Crohn's disease: Current management
    • Dignass A, Van Assche G, Lindsay JO, et al. The second European evidence-based consensus on the diagnosis and management of Crohn's disease: Current management. J Crohn's Colitis 2010; 4: 28-62.
    • (2010) J Crohn's Colitis , vol.4 , pp. 28-62
    • Dignass, A.1    Van Assche, G.2    Lindsay, J.O.3
  • 16
    • 84877903991 scopus 로고    scopus 로고
    • accessed 13 August 2012
    • National Comprehensive Cancer Network. Guidelines on treatment on non-Hodgkin lymphoma, http://www.nccn.org/professionals/physician-gls/f- guidelinesasp (2012, accessed 13 August 2012).
    • (2012) Guidelines on Treatment on Non-Hodgkin Lymphoma
  • 17
    • 78049362302 scopus 로고    scopus 로고
    • WHO/BS/09.2110, accessed 13 August 2012
    • WHO. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO/BS/09.2110, http://www.who.int/biologicals/publications/trs/areas/ biological-therapeutics/BS2110Dft-guidelines-Final-HK-IK-29July-09.pdf (2009, accessed 13 August 2012).
    • (2009) Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)
  • 20
    • 84873952002 scopus 로고    scopus 로고
    • accessed 13 August 2012
    • Sherman RE. Biosimilar biological products, http://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM292463.pdf (2012, accessed 13 August 2012).
    • (2012) Biosimilar Biological Products
    • Sherman, R.E.1
  • 21
    • 84863218474 scopus 로고    scopus 로고
    • Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars
    • Berkowitz SA, Engen JR, Mazzeo JR, et al. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nature Rev Drug Disc 2012; 11: 527-540.
    • (2012) Nature Rev Drug Disc , vol.11 , pp. 527-540
    • Berkowitz, S.A.1    Engen, J.R.2    Mazzeo, J.R.3
  • 22
    • 77952118055 scopus 로고    scopus 로고
    • accessed 13 August 2012
    • EMA. Tysabri: Summary of Product Characteristics, http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Product-Information/human/000603/ WC500044686.pdf (2012, accessed 13 August 2012).
    • (2012) Tysabri: Summary of Product Characteristics
  • 23
    • 84877893646 scopus 로고    scopus 로고
    • accessed 13 August 2012
    • Citiline. Drug development overview: Biosimilar monoclonal antibodies, http://www.citeline.com/wp-content/uploads/Drug-Development-Overview-Biosimilar- Monoclonal-Antibodies-16-May-2012.pdf (2012, accessed 13 August 2012).
    • (2012) Drug Development Overview: Biosimilar Monoclonal Antibodies
  • 24
    • 84877919534 scopus 로고    scopus 로고
    • accessed 13 August 2012
    • Celltrion. KFDA approves Remsima, www.celltrion.com (2012, accessed 13 August 2012).
    • (2012) KFDA Approves Remsima
  • 25
    • 79959924862 scopus 로고    scopus 로고
    • Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: Position of the World Marrow Donor Association
    • Shaw BE, Confer DL, Hwang WY, et al. Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: position of the World Marrow Donor Association. Haematologica 2011; 96: 942-947.
    • (2011) Haematologica , vol.96 , pp. 942-947
    • Shaw, B.E.1    Confer, D.L.2    Hwang, W.Y.3
  • 26
    • 79958824101 scopus 로고    scopus 로고
    • Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies
    • Praditpornsilpa K, Tiranathanagul K, Kupatawintu P, et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int 2011; 80: 88-92.
    • (2011) Kidney Int , vol.80 , pp. 88-92
    • Praditpornsilpa, K.1    Tiranathanagul, K.2    Kupatawintu, P.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.