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Volumn 33, Issue 5, 2015, Pages 250-252

Biosimilars and the long game

Author keywords

Biosimilar; Follow on biologic; Subsequent entry biologic

Indexed keywords

BIOSIMILAR AGENT; GENERIC DRUG;

EID: 84928014582     PISSN: 01677799     EISSN: 18793096     Source Type: Journal    
DOI: 10.1016/j.tibtech.2015.01.001     Document Type: Note
Times cited : (11)

References (10)
  • 2
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    • Biosimilars Approved in Europe, GaBi. Published online November 14, 2014.
    • Generics and Biosimilars Initiative (2014) Biosimilars Approved in Europe, GaBi. Published online November 14, 2014. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe.
    • (2014)
  • 3
    • 84877300355 scopus 로고    scopus 로고
    • Building a wall against biosimilars
    • Editorial Building a wall against biosimilars. Nat. Biotechnol. 2013, 31:264.
    • (2013) Nat. Biotechnol. , vol.31 , pp. 264
  • 5
    • 84994548779 scopus 로고    scopus 로고
    • Questions and Answers To Accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), Health Canada.
    • Published online May 27, 2010.
    • Health Canada (2010) Questions and Answers To Accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), Health Canada. Published online May 27, 2010. http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/01-2010-seb-pbu-qa-qr-eng.php.
    • (2010)
  • 6
    • 84928009850 scopus 로고    scopus 로고
    • Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, FDA
    • Published online January 27, 2015.
    • US Food and Drug Administration (2014) Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, FDA. Published online January 27, 2015. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm411418.htm.
    • (2014)
  • 7
    • 51349137409 scopus 로고    scopus 로고
    • Toward biosimilar monoclonal antibodies
    • Schneider C.K., Kalinke U. Toward biosimilar monoclonal antibodies. Nat. Biotechnol. 2008, 26:985-990.
    • (2008) Nat. Biotechnol. , vol.26 , pp. 985-990
    • Schneider, C.K.1    Kalinke, U.2
  • 8
    • 84928045942 scopus 로고    scopus 로고
    • Assessment Report: Remsima.
    • International Non-Proprietary Name: Infliximab, EMA. Published online June 27, 2013.
    • European Medicines Agency (2013) Assessment Report: Remsima. International Non-Proprietary Name: Infliximab, EMA. Published online June 27, 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf.
    • (2013)
  • 9
    • 84928009849 scopus 로고    scopus 로고
    • The next move in biopharma. Chemistry and Industry Magazine 24.
    • Published online December 20, 2010.
    • Dorey, E. (2010) The next move in biopharma. Chemistry and Industry Magazine 24. Published online December 20, 2010. http://www.soci.org/Chemistry-and-Industry/CnI-Data/2010/24/The-next-move-in-biopharma.
    • (2010)
    • Dorey, E.1
  • 10
    • 80051870332 scopus 로고    scopus 로고
    • Manufacturing strategies for biosimilars
    • Lee A., et al. Manufacturing strategies for biosimilars. Pharm. Technol. 2011, 35:36.
    • (2011) Pharm. Technol. , vol.35 , pp. 36
    • Lee, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.