메뉴 건너뛰기




Volumn 40, Issue SUPPL.1, 2013, Pages S5-

Developing oncology biosimilars: An essential approach for the future

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; BORTEZOMIB; CETUXIMAB; DOCETAXEL; ERYTHROPOIETIN; GEMCITABINE; GENERIC DRUG; GROWTH HORMONE; LEUPRORELIN; OXALIPLATIN; PEMETREXED; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; TRASTUZUMAB;

EID: 84888391581     PISSN: 00937754     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.seminoncol.2013.09.015     Document Type: Article
Times cited : (27)

References (49)
  • 1
    • 80054922640 scopus 로고    scopus 로고
    • NCCN Biosimilars White Paper: Regulatory, scientific, and patient safety perspectives
    • A.D. Zelenetz, I. Ahmed, and E.L. Braud NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives J Natl Compr Canc Netw 9 Suppl 4 2011 S1 22
    • (2011) J Natl Compr Canc Netw , vol.9 , Issue.SUPPL. 4 , pp. 1-22
    • Zelenetz, A.D.1    Ahmed, I.2    Braud, E.L.3
  • 2
    • 84872175228 scopus 로고    scopus 로고
    • Biosimilar monoclonal antibodies: A science-based regulatory challenge
    • P.J. Declerck Biosimilar monoclonal antibodies: a science-based regulatory challenge Expert Opin Biol Ther 13 2013 153 156
    • (2013) Expert Opin Biol Ther , vol.13 , pp. 153-156
    • Declerck, P.J.1
  • 3
    • 84888359760 scopus 로고    scopus 로고
    • Generics and biosimilar initiative
    • Accessed July 24, 2013
    • Generics and Biosimilar Initiative. Biosimilars in oncology: current and future perspectives. gabi-journal.net/biosimilars-in-oncology-current-and- future-perspectives.html. Accessed July 24, 2013.
    • Biosimilars in Oncology: Current and Future Perspectives
  • 4
    • 69449095403 scopus 로고    scopus 로고
    • Biosimilar therapeutics-what do we need to consider?
    • H. Schellekens Biosimilar therapeutics-what do we need to consider? NDT Plus 2 Suppl 1 2009 i27 i36
    • (2009) NDT Plus , vol.2 , Issue.SUPPL. 1
    • Schellekens, H.1
  • 5
    • 84888320708 scopus 로고    scopus 로고
    • United States House of Representatives Published March 13, 2013. Accessed July 19
    • United States House of Representatives. United States Public Health Services Act. www.house.gov/legcoun/Comps/PHSA-CMD.pdf. Published March 13, 2013. Accessed July 19, 2013.
    • (2013) United States Public Health Services Act
  • 6
    • 84888349339 scopus 로고    scopus 로고
    • FDA definitions of generics and biosimilars. Accessed July 19, 2013
    • Generics and Biosimilar Initiative. FDA definitions of generics and biosimilars. http://gabionline.net/Biosimilars/General/FDA-definitions-of- generics-and-biosimilars. Accessed July 19, 2013.
    • Generics and Biosimilar Initiative
  • 7
    • 84866933842 scopus 로고    scopus 로고
    • Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development
    • X.Y. Cai, J. Thomas, C. Cullen, and D. Gouty Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development Bioanalysis 4 2012 2169 2177
    • (2012) Bioanalysis , vol.4 , pp. 2169-2177
    • Cai, X.Y.1    Thomas, J.2    Cullen, C.3    Gouty, D.4
  • 8
    • 84862581676 scopus 로고    scopus 로고
    • Comparability and biosimilarity: Considerations for the healthcare provider
    • J.F. Lee, J.B. Litten, and G. Grampp Comparability and biosimilarity: considerations for the healthcare provider Curr Med Res Opin 28 2012 1053 1058
    • (2012) Curr Med Res Opin , vol.28 , pp. 1053-1058
    • Lee, J.F.1    Litten, J.B.2    Grampp, G.3
  • 9
    • 33748687181 scopus 로고    scopus 로고
    • The protein science of biosimilars
    • M. Kuhlmann, and A. Covic The protein science of biosimilars Nephrol Dial Transplant 21 Suppl 5 2006 v4 v8
    • (2006) Nephrol Dial Transplant , vol.21 , Issue.SUPPL. 5
    • Kuhlmann, M.1    Covic, A.2
  • 10
    • 84873940514 scopus 로고    scopus 로고
    • Understanding and incentivizing biosimilars
    • J. Kanter, and R. Feldman Understanding and incentivizing biosimilars Hastings Law J 64 2012 57 83
    • (2012) Hastings Law J , vol.64 , pp. 57-83
    • Kanter, J.1    Feldman, R.2
  • 11
    • 84871856579 scopus 로고    scopus 로고
    • A non-interventional study of biosimilar granulocyte colony-stimulating factor as prophylaxis for chemotherapy-induced neutropenia in a community oncology centre
    • K. Verpoort, and T.M. Möhler A non-interventional study of biosimilar granulocyte colony-stimulating factor as prophylaxis for chemotherapy-induced neutropenia in a community oncology centre Ther Adv Med Oncol 4 2012 289 293
    • (2012) Ther Adv Med Oncol , vol.4 , pp. 289-293
    • Verpoort, K.1    Möhler, T.M.2
  • 12
    • 38349138848 scopus 로고    scopus 로고
    • Association of insurance with cancer care utilization and outcomes
    • E. Ward, M. Halpern, and N. Schrag Association of insurance with cancer care utilization and outcomes CA Cancer J Clin 58 2008 9 31
    • (2008) CA Cancer J Clin , vol.58 , pp. 9-31
    • Ward, E.1    Halpern, M.2    Schrag, N.3
  • 13
    • 77957723026 scopus 로고    scopus 로고
    • Biosimilar epoetins and other "follow-on" biologics: Update on the European experiences
    • W. Jelkmann Biosimilar epoetins and other "follow-on" biologics: update on the European experiences Am J Hematol 85 2010 771 780
    • (2010) Am J Hematol , vol.85 , pp. 771-780
    • Jelkmann, W.1
  • 14
    • 84875477617 scopus 로고    scopus 로고
    • The continuum of comparability extends to biosimilarity: How much is enough and what clinical data are necessary?
    • M. McCamish, and G. Woollett The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary? Clin Pharmacol Ther 93 2013 315 317
    • (2013) Clin Pharmacol Ther , vol.93 , pp. 315-317
    • McCamish, M.1    Woollett, G.2
  • 15
    • 79952749322 scopus 로고    scopus 로고
    • Biosimilar agents in oncology/haematology: From approval to practice
    • D. Niederwieser, and S. Schmitz Biosimilar agents in oncology/ haematology: from approval to practice Eur J Haematol 86 2011 277 288
    • (2011) Eur J Haematol , vol.86 , pp. 277-288
    • Niederwieser, D.1    Schmitz, S.2
  • 16
    • 84872578140 scopus 로고    scopus 로고
    • Follow-on biologics in oncology - The need for global and local regulations
    • I. Hus Follow-on biologics in oncology-the need for global and local regulations Wspolczesna Onkol 16 2012 461 466
    • (2012) Wspolczesna Onkol , vol.16 , pp. 461-466
    • Hus, I.1
  • 17
    • 84860285348 scopus 로고    scopus 로고
    • On the regulatory approval pathway of biosimilar products
    • J. Wang, and S.-C. Chow On the regulatory approval pathway of biosimilar products Pharmaceuticals 5 2012 353 368
    • (2012) Pharmaceuticals , vol.5 , pp. 353-368
    • Wang, J.1    Chow, S.-C.2
  • 18
    • 84888352191 scopus 로고    scopus 로고
    • Generics and biosimilar initiative
    • Accessed July 19, 2013
    • Generics and Biosimilar Initiative. Hurdles to biosimilars in Asia. http://gabionline.net/Biosimilars/General/Hurdles-to-biosimilars-in-Asia. Accessed July 19, 2013.
    • Hurdles to Biosimilars in Asia
  • 20
    • 79957771210 scopus 로고    scopus 로고
    • Insurance status and racial differences in uterine cancer survival: A study of patients in the National Cancer Database
    • S.A. Fedewa, C. Lerro, D. Chase, and E.M. Ward Insurance status and racial differences in uterine cancer survival: a study of patients in the National Cancer Database Gynecol Oncol 122 2011 63 68
    • (2011) Gynecol Oncol , vol.122 , pp. 63-68
    • Fedewa, S.A.1    Lerro, C.2    Chase, D.3    Ward, E.M.4
  • 22
    • 70349589392 scopus 로고    scopus 로고
    • Federal Trade Commission Federal Trade Commission Washington, DC Accessed July 19, 2013
    • Federal Trade Commission Emerging health care issues: follow-on biologic drug competition 2009 Federal Trade Commission Washington, DC http://www.ftc.gov/os/2009/06/P083901biologicsreport.pdf Accessed July 19, 2013
    • (2009) Emerging Health Care Issues: Follow-on Biologic Drug Competition
  • 23
    • 40149095089 scopus 로고    scopus 로고
    • The challenge of biosimilars
    • DOI 10.1093/annonc/mdm345
    • H. Mellstedt, D. Niederwieser, and H. Ludwig The challenge of biosimilars Ann Oncol 19 2008 411 419 (Pubitemid 351325660)
    • (2008) Annals of Oncology , vol.19 , Issue.3 , pp. 411-419
    • Mellstedt, H.1    Niederwieser, D.2    Ludwig, H.3
  • 24
    • 33748685217 scopus 로고    scopus 로고
    • Comparative testing and pharmacovigilance of biosimilars
    • F. Locatelli, and S. Roger Comparative testing and pharmacovigilance of biosimilars Nephrol Dial Transplant 21 Suppl 5 2006 v13 v16
    • (2006) Nephrol Dial Transplant , vol.21 , Issue.SUPPL. 5
    • Locatelli, F.1    Roger, S.2
  • 25
    • 84888342326 scopus 로고    scopus 로고
    • Generics and Biosimilar Initiative Accessed July 19, 2013
    • Generics and Biosimilar Initiative. US$54 billion worth of biosimilar patents expiring before 2020. http://www.gabionline.net/Biosimilars/ Research/US-54-billion-worth-of-biosimilar-patents-expiring-before-2020. Accessed July 19, 2013.
    • US$54 Billion Worth of Biosimilar Patents Expiring before 2020
  • 27
    • 84873712388 scopus 로고    scopus 로고
    • Innovation and competition: Will biosimilars succeed?
    • E.A. Blackstone, and J.P. Fuhr Jr Innovation and competition: will biosimilars succeed? Biotechnol Healthc 9 2012 24 27
    • (2012) Biotechnol Healthc , vol.9 , pp. 24-27
    • Blackstone, E.A.1    Fuhr, Jr.J.P.2
  • 28
    • 34548147147 scopus 로고    scopus 로고
    • Basic facts about biosimilars
    • DOI 10.1159/000105133
    • M. Nowicki Basic facts about biosimilars Kidney Blood Press Res 30 2007 267 272 (Pubitemid 47482057)
    • (2007) Kidney and Blood Pressure Research , vol.30 , Issue.5 , pp. 267-272
    • Nowicki, M.1
  • 29
    • 45149128290 scopus 로고    scopus 로고
    • Current perspectives on stability of protein drug products during formulation, fill and finish operations
    • DOI 10.1021/bp070462h
    • N. Rathore, and R.S. Rajan Current perspectives on stability of protein drug products during formulation, fill and finish operations Biotechnol Prog 24 2008 504 514 (Pubitemid 351832704)
    • (2008) Biotechnology Progress , vol.24 , Issue.3 , pp. 504-514
    • Rathore, N.1    Rajan, R.S.2
  • 30
    • 84857899040 scopus 로고    scopus 로고
    • Risk management of biosimilars in oncology: Each medicine is a work in progress
    • A.G. Vulto, and S.A. Crow Risk management of biosimilars in oncology: each medicine is a work in progress Targ Oncol 7 Suppl 1 2012 S43 S49
    • (2012) Targ Oncol , vol.7 , Issue.SUPPL. 1
    • Vulto, A.G.1    Crow, S.A.2
  • 31
    • 33644952525 scopus 로고    scopus 로고
    • European Medicines Agency Published May 22, 2013. Accessed July 19, 2013
    • European Medicines Agency. Guideline on similar biological medicinal products. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2013/05/WC500142978.pdf. Published May 22, 2013. Accessed July 19, 2013.
    • Guideline on Similar Biological Medicinal Products
  • 32
    • 84888371592 scopus 로고    scopus 로고
    • DrugBank Updated February 8, 2013. Accessed July 19, 2013
    • DrugBank. Acetylsalicylic acid. http://www.drugbank.ca/drugs/DB00945. Updated February 8, 2013. Accessed July 19, 2013.
    • Acetylsalicylic Acid
  • 33
    • 84888347144 scopus 로고    scopus 로고
    • DrugBank. Trastuzumab. Updated July 14, 2011. Accessed July 19, 2013.
    • DrugBank. Trastuzumab. http://www.drugbank.ca/drugs/DB00072. Updated July 14, 2011. Accessed July 19, 2013.
  • 35
    • 78049362302 scopus 로고    scopus 로고
    • World Health Organization Accessed July 19, 2013
    • World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs). http://www.who.int/biologicals/areas/biological- therapeutics/BIOTHERAPEUTICS-FOR-WEB-22APRIL2010.pdf. Accessed July 19, 2013.
    • Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)
  • 36
    • 84862935674 scopus 로고    scopus 로고
    • Biopharmaceuticals and biosimilars in psoriasis: What the dermatologist needs to know
    • B.E. Strober, K. Armour, and R. Romiti Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know J Am Acad Dermatol 66 2012 317 322
    • (2012) J Am Acad Dermatol , vol.66 , pp. 317-322
    • Strober, B.E.1    Armour, K.2    Romiti, R.3
  • 37
    • 33947660965 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins. Part 3: Impact of manufacturing changes
    • DOI 10.1016/j.biotechadv.2007.01.007, PII S0734975007000249
    • B. Sharma Immunogenicity of therapeutic proteins. Part 3: Impact of manufacturing changes Biotechnol Adv 25 2007 325 331 (Pubitemid 46498674)
    • (2007) Biotechnology Advances , vol.25 , Issue.3 , pp. 325-331
    • Sharma, B.1
  • 39
    • 84878900689 scopus 로고    scopus 로고
    • Pharmacovigilance and biosimilars: Considerations, needs and challenges
    • N. Casadevall, I.R. Edwards, and T. Felix Pharmacovigilance and biosimilars: considerations, needs and challenges Expert Opin Biol Ther 13 2013 1039 1047
    • (2013) Expert Opin Biol Ther , vol.13 , pp. 1039-1047
    • Casadevall, N.1    Edwards, I.R.2    Felix, T.3
  • 40
    • 25444452228 scopus 로고    scopus 로고
    • Department of Health and Human Services Food and Drug Administration US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Rockville, MD
    • Department of Health and Human Services. Food and Drug Administration. Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment. US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Rockville, MD; 2005
    • (2005) Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
  • 41
    • 0036598634 scopus 로고    scopus 로고
    • Bioequivalence and the immunogenicity of biopharmaceuticals
    • H. Schellekens Bioequivalence and the immunogenicity of biopharmaceuticals Nat Rev Drug Discov 1 2002 457 462 (Pubitemid 37361488)
    • (2002) Nature Reviews Drug Discovery , vol.1 , Issue.6 , pp. 457-462
    • Schellekens, H.1
  • 43
    • 35748959960 scopus 로고    scopus 로고
    • Pure red-cell aplasia "epidemic"-mystery completely revealed?
    • F. Locatelli, L. Del Vecchio, and P. Pozzoni Pure red-cell aplasia "epidemic"-mystery completely revealed? Perit Dial Int 27 Suppl 2 2007 S303 S307
    • (2007) Perit Dial Int , vol.27 , Issue.SUPPL. 2
    • Locatelli, F.1    Del Vecchio, L.2    Pozzoni, P.3
  • 45
    • 84859424243 scopus 로고    scopus 로고
    • Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: New insights
    • I.C. Macdougall, S.D. Roger, and A. de Francisco Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights Kidney Int 81 2012 727 732
    • (2012) Kidney Int , vol.81 , pp. 727-732
    • MacDougall, I.C.1    Roger, S.D.2    De Francisco, A.3
  • 47
    • 84888378758 scopus 로고    scopus 로고
    • How similar are biosimilars in India? A blind comparative study
    • Accessed July 20, 2013
    • R. Mody, V. Goradia, and D. Gupta How similar are biosimilars in India? A blind comparative study Pharma Focus Asia 11 2010 www.pharmafocusasia.com/ research-development/blind-comparative-study.html Accessed July 20, 2013
    • (2010) Pharma Focus Asia , vol.11
    • Mody, R.1    Goradia, V.2    Gupta, D.3
  • 48
    • 84877997856 scopus 로고    scopus 로고
    • Implications of the FDA draft guidance on biosimilars for clinicians: What we know and don't know
    • E. Li, and J.M. Hoffman Implications of the FDA draft guidance on biosimilars for clinicians: what we know and don't know J Natl Compr Canc Netw 11 2013 368 372
    • (2013) J Natl Compr Canc Netw , vol.11 , pp. 368-372
    • Li, E.1    Hoffman, J.M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.