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Volumn 39, Issue 1, 2014, Pages 60-71

The portuguese society of rheumatology position paper on the use of biosimilars

(42)  Fonseca, João Eurico a   Gonçalves, João b   Araújo, Filipe b   Cordeiro, Inês b   Teixeira, Filipa b   Canhão, Helena b   Jose Antonio Pereira da Silva b   Garcês, Sandra b   Miranda, Luís Cunha b   Ramiro, Sofia b   Roxo, Ana b   Pimentel Santos, Fernando M b   Tavares, Viviana b   Neto, Adriano b   Sepriano, Alexandre b   Malcata, Armando b   Faustino, Augusto b   Silva, Cândida b   Ambrósio, Catarina b   Duarte, Cátia b   more..

b NONE

Author keywords

Ankylosing spondylitis; Automatic substitution; Biosimilar; Extrapolation; Infliximab; Interchangeability; Position paper; Review; Rheumatoid arthritis; Switching

Indexed keywords

BIOSIMILAR AGENT;

EID: 84897545473     PISSN: 0303464X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (30)

References (44)
  • 1
    • 84897543708 scopus 로고    scopus 로고
    • Biotechnology Industry Organization website, Accessed in December 19th
    • Biotechnology Industry Organization website. http://www. bio.org/node/517. Accessed in December 19th, 2011.
    • (2011)
  • 2
    • 84897524315 scopus 로고    scopus 로고
    • Volume 9A of The Rules Governing Medicinal Products in the European Union. European Medicines Agency, September, Accessed in August 2nd, 2012.
    • Volume 9A of The Rules Governing Medicinal Products in the European Union. European Medicines Agency, September 2008. http://ec.europa.eu/health/files/eudralex/vol- 9/pdf/ vol9a_09-2008_en.pdf. Accessed in August 2nd, 2012.
    • (2008)
  • 3
    • 84897492969 scopus 로고    scopus 로고
    • Guideline on Immunogenicity Assessment of Biotechnology- Derived Therapeutic Proteins. European Medicines Agency, 2007, Accessed in July 3rd
    • Guideline on Immunogenicity Assessment of Biotechnology- Derived Therapeutic Proteins. European Medicines Agency, 2007. http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/ WC500003947.pdf. Accessed in July 3rd, 2012.
    • (2012)
  • 4
    • 79952744875 scopus 로고    scopus 로고
    • Worldwide experience with biosimilar development
    • McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs 2011; 3: 209-217.
    • (2011) MAbs , vol.3 , pp. 209-217
    • McCamish, M.1    Woollett, G.2
  • 6
    • 84897547068 scopus 로고    scopus 로고
    • ICH harmonised tripartite guideline: comparability of biotechnological/ biological products subject to changes in their manufacturing process Q5E, November 2004, Accessed in November
    • ICH harmonised tripartite guideline: comparability of biotechnological/ biological products subject to changes in their manufacturing process Q5E. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. November 2004. http://www.ich.org/ fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf. Accessed in November 2013.
    • (2013) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • 8
    • 84897548586 scopus 로고    scopus 로고
    • European Medicines Agency Scientific Guidance Documents on Biosimilar Medicines, Accessed in September 4th
    • European Medicines Agency Scientific Guidance Documents on Biosimilar Medicines. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_ 000408.jsp&murl=menus/regulations/regulations.jsp &mid=WC0b01ac058002958c&jsenabled=true. Accessed in September 4th, 2012.
    • (2012)
  • 9
    • 74049092678 scopus 로고    scopus 로고
    • Clinical comparability and European biosimilar regulations
    • Schellekens H, Moors E. Clinical comparability and European biosimilar regulations. Nat Biotechnol 2010; 28: 28-31.
    • (2010) Nat Biotechnol , vol.28 , pp. 28-31
    • Schellekens, H.1    Moors, E.2
  • 10
    • 79551563213 scopus 로고    scopus 로고
    • Comparability assessments of process and product changes made during development of two different monoclonal antibodies
    • Lubiniecki A, Volkin DB, Federici M, et al. Comparability assessments of process and product changes made during development of two different monoclonal antibodies. Biologicals 2011; 39: 9-22.
    • (2011) Biologicals , vol.39 , pp. 9-22
    • Lubiniecki, A.1    Volkin, D.B.2    Federici, M.3
  • 11
    • 79955655456 scopus 로고    scopus 로고
    • Biosimilars 2.0: Guiding principles for a global 'patients first' standard
    • Miletich J, Eich G, Grampp G, et al. Biosimilars 2.0: Guiding principles for a global 'patients first' standard. MAbs 2011; 3: 318-325.
    • (2011) MAbs , vol.3 , pp. 318-325
    • Miletich, J.1    Eich, G.2    Grampp, G.3
  • 12
    • 84937027579 scopus 로고    scopus 로고
    • European Medicines Agency, accessed 11 Oct
    • European Medicines Agency. EPAR summary for the public - Inflectra. http://www.ema.europa.eu/docs/en_GB/document_ library/EPAR_-_Summary_for_the_public/human/002778/WC500151491.pdf (accessed 11 Oct 2013).
    • (2013) EPAR summary for the public - Inflectra
  • 13
    • 84897546932 scopus 로고    scopus 로고
    • European Medicines Agency. EPAR summary for the public - Remsima, (accessed 11 Oct 2013
    • European Medicines Agency. EPAR summary for the public - Remsima. http://www.ema.europa.eu/docs/en_GB/document_ library/EPAR_-_Summary_for_the_public/human/002576/WC500150872.pdf (accessed 11 Oct 2013).
  • 14
    • 84883746909 scopus 로고    scopus 로고
    • A randomised, double blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study
    • Ann Rheum Dis Published Online First 16 May 2013. doi:10.1136/annrheumdis-2012-203091
    • Park W, Hrycaj P, Jeka S, et al. A randomised, double blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis Published Online First 16 May 2013. doi:10.1136/annrheumdis-2012- 203091.
    • Park, W.1    Hrycaj, P.2    Jeka, S.3
  • 15
    • 84883752718 scopus 로고    scopus 로고
    • randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study
    • Ann Rheum Dis Published Online First 16 May, doi:10.1136/ann - rheumdis-2012-203090
    • Yoo D, Hrycaj P, Miranda P, et al. randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis Published Online First 16 May 2013. doi:10.1136/ann - rheumdis-2012-203090.
    • (2013)
    • Yoo, D.1    Hrycaj, P.2    Miranda, P.3
  • 16
    • 84897542771 scopus 로고    scopus 로고
    • Committee on Rheumatologic Care, American College of Rheumatology, Accessed in September 29th 2013.
    • Committee on Rheumatologic Care. Position statement on biosimilars. American College of Rheumatology, 2010. www.rheumatology.org/practice/clinical/position/biosimilars. pdf. Accessed in September 29th, 2013.
    • (2010) Position statement on biosimilars
  • 17
    • 84875377912 scopus 로고    scopus 로고
    • Biosimilar drugs in Mexico: position of the Mexican College of Rheumatology, 2012
    • Espinosa Morales R, Díaz Borjón A, Barile Fabris LA, et al. Biosimilar drugs in Mexico: position of the Mexican College of Rheumatology, 2012. Reumatol Clin 2013; 9: 113-116.
    • (2013) Reumatol Clin , vol.9 , pp. 113-116
    • Espinosa Morales, R.1    Díaz Borjón, A.2    Barile Fabris, L.A.3
  • 18
    • 84897511224 scopus 로고    scopus 로고
    • Position Statement on Generic Therapeutic & Biosimilar Substitution. American Academy of Dermatology and AAD Association, Accessed in September 30th 2013
    • Position Statement on Generic Therapeutic & Biosimilar Substitution. American Academy of Dermatology and AAD Association, 2012. http://www.aad.org/Forms/Policies/Uploads/PS/PS-Therapeutic%20Substitution.pdf. Accessed in September 30th, 2013.
    • (2012)
  • 19
    • 84878624235 scopus 로고    scopus 로고
    • ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)
    • Governing Board and Operational Board of ECCO
    • Danese S, Gomollon F; Governing Board and Operational Board of ECCO. ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013;7:586-589.
    • (2013) J Crohns Colitis. , vol.7 , pp. 586-589
    • Danese, S.1    Gomollon, F.2
  • 20
    • 84878532312 scopus 로고    scopus 로고
    • Joint position statement by Spanish Society of Gastroenterology and Spanish Society of Pharmacology on biosimilar therapy for inflammatory bowel disease
    • Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T. Joint position statement by Spanish Society of Gastroenterology and Spanish Society of Pharmacology on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig. 2013; 105: 37-43.
    • (2013) Rev Esp Enferm Dig. , vol.105 , pp. 37-43
    • Argüelles-Arias, F.1    Barreiro-de-Acosta, M.2    Carballo, F.3    Hinojosa, J.4    Tejerina, T.5
  • 22
    • 79959992578 scopus 로고    scopus 로고
    • 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
    • Barosi G, Bosi A, Abbracchio MP, 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 2011; 96: 937-942.
    • (2011) Haematologica , vol.96 , pp. 937-942
    • Barosi, G.1    Bosi, A.2    Abbracchio, M.P.3
  • 23
    • 84862228867 scopus 로고    scopus 로고
    • Ensuring safety of biosimilar low- -molecular-weight heparins: a consensus statement of the International Union of Angiology
    • Working Group of the IUA Scientific Committee,
    • Harenberg J, Kalodiki E, Walenga JM; Working Group of the IUA Scientific Committee. Ensuring safety of biosimilar low- -molecular-weight heparins: a consensus statement of the International Union of Angiology. Int Angiol 2012; 31: 101- -104.
    • (2012) Int Angiol , vol.31 , pp. 101-104
    • Harenberg, J.1    Kalodiki, E.2    Walenga, J.M.3
  • 24
    • 84897512078 scopus 로고    scopus 로고
    • Recommandations d'utilisation des biosimilaires de l'Erythropoïétine (EPO). Société Française de Néphrologie/Société Francophone de Dyalise, Accessed in September 29th, 2013
    • Recommandations d'utilisation des biosimilaires de l'Erythropoïétine (EPO). Société Française de Néphrologie/Société Francophone de Dyalise, 2009. http://www.soc-nephrologie. org/PDF/esociete/groupes/biosimilaires.pdf. Accessed in September 29th, 2013.
    • (2009)
  • 25
    • 84897510383 scopus 로고    scopus 로고
    • Biosimilar substitution. National Psoriasis Foundation Medical Board website, Accessed in September 30th, 2013
    • Biosimilar substitution. National Psoriasis Foundation Medical Board website, 2013. http://www.psoriasis.org/aboutpsoriasis/treatments/statement-on-biosimilars. Accessed in September 30th, 2013.
    • (2013)
  • 26
    • 84897493137 scopus 로고    scopus 로고
    • NCCN Oncology Policy Summit: Biosimilars - Regulatory, Scientific, and Patient Safety Perspectives. National Comprehensive Cancer Network, Accessed in October 1st, 2013
    • NCCN Oncology Policy Summit: Biosimilars - Regulatory, Scientific, and Patient Safety Perspectives. National Comprehensive Cancer Network, 2011. http://www.nccn.org/professionals/meetings/oncology_policy_program/biosimilars. aspx. Accessed in October 1st, 2013.
    • (2011)
  • 27
    • 84897506877 scopus 로고    scopus 로고
    • Docket No. FDA-2010-N-0477 Approval Pathway for Biosimilar and Interchangeable Biological Products. National Haemophilia Foundation, Accessed in September 28th, 2013
    • Docket No. FDA-2010-N-0477 Approval Pathway for Biosimilar and Interchangeable Biological Products. National Haemophilia Foundation, 2010. http://www.hemophilia. org/NHFWeb/Resource/StaticPages/menu0/menu7/menu12 2/NHF_FDABiosimilars.pdf. Accessed in September 28th, 2013.
    • (2010)
  • 28
    • 84897491507 scopus 로고    scopus 로고
    • Position statement on biosimilar insulins. Diabetes UK, Accessed in October 1st, 2013
    • Position statement on biosimilar insulins. Diabetes UK, 2013. http://www.diabetes.org.uk/Documents/Position% 20statements/diabetes-uk-position-statement-biosimilar- insulins-1013.pdf. Accessed in October 1st, 2013.
    • (2013)
  • 29
    • 84897496474 scopus 로고    scopus 로고
    • EBE-EFPIA position paper: labelling of biosimilar medicinal products. European Biopharmaceutical Enterprises/European Federation of Pharmaceutical Industries and Associations, Accessed in September 27th, 2013
    • EBE-EFPIA position paper: labelling of biosimilar medicinal products. European Biopharmaceutical Enterprises/European Federation of Pharmaceutical Industries and Associations, 2007.http://www.biofarmacos.org/files/contenido/Ebe-Efpia_Biosimilars_labelling_position_paper_28_mar_07.pdf Accessed in September 27th, 2013.
    • (2007)
  • 30
    • 84897547440 scopus 로고    scopus 로고
    • Background Paper by BIO Deutschland on Biosimilars. Biotechnology Industry Organization Deutschland, Accessed in September 30th, 2013
    • Background Paper by BIO Deutschland on Biosimilars. Biotechnology Industry Organization Deutschland, 2012. http://www.biodeutschland.org/tl_files/content_eng/Position% 20papers/2012/120306_FIN_Hintergrundpapier_Biosimilars% 20_ENGLISCH.pdf. Accessed in September 30th, 2013.
    • (2012)
  • 31
    • 84897551404 scopus 로고    scopus 로고
    • Similar biotherapeutic products: scientific and regulatory considerations. International Federation of Pharmaceutical Manufacturers and Associations, Accessed in September 29th, 2013
    • Similar biotherapeutic products: scientific and regulatory considerations. International Federation of Pharmaceutical Manufacturers and Associations, 2011. http://www.ifpma. org/fileadmin/content/Publication/2013/IFPMA_BiosimilarWEB. pdf. Accessed in September 29th, 2013.
    • (2011)
  • 32
    • 84897543851 scopus 로고    scopus 로고
    • OPPI position paper on biosimilars. Organisation of Pharmaceutical Producers of India, Accessed in September 30th, 2013
    • OPPI position paper on biosimilars. Organisation of Pharmaceutical Producers of India, 2012. http://www.indiaoppi. com/oppibiosimilars.pdf. Accessed in September 30th, 2013.
    • (2012)
  • 33
    • 84897554806 scopus 로고    scopus 로고
    • Biosimilars: position paper. Belgian Biotechnology Industry Organization, Essenscia, Accessed in October 1st, 2013
    • Biosimilars: position paper. Belgian Biotechnology Industry Organization, Essenscia, 2013. http://www.essenscia.be/Upload/Docs/BiosimilarsBio-E.pdf. Accessed in October 1st, 2013.
    • (2013)
  • 34
    • 84897532615 scopus 로고    scopus 로고
    • Biosimilars: GPhA position. Generic Pharmaceutical Association, Accessed in September 28th, 2013
    • Biosimilars: GPhA position. Generic Pharmaceutical Association, 2013. http://www.gphaonline.org/issues/biosimilars. Accessed in September 28th, 2013.
    • (2013)
  • 35
    • 84897526798 scopus 로고    scopus 로고
    • ABPI position on biosimilar medicines. Association of the British Pharmaceutical Industry, Accessed in September 29th, 2013
    • ABPI position on biosimilar medicines. Association of the British Pharmaceutical Industry, 2013. http://www.abpi.org. uk/_layouts/download.aspx?SourceUrl=/our-work/library/industry/Documents/ABPI%20biosimilars%20position% 20paper.pdf Accessed in September 29th, 2013.
    • (2013)
  • 36
    • 84897534019 scopus 로고    scopus 로고
    • Position paper: biossimilares. Apifarma, Accessed in September 29th, 2013
    • Position paper: biossimilares. Apifarma, 2013. http://www. apifarma.pt/areas/biotecnologia/Documents/PostionPaper- Biossimilares_APIFARMA_Abril2013.pdf. Accessed in September 29th, 2013.
    • (2013)
  • 37
    • 84897512736 scopus 로고    scopus 로고
    • Biosimilars: MISG panel & forum topic proposal. Department of Health's Ministerial Industry Strategy Group, Accessed in September 30th, 2013
    • Biosimilars: MISG panel & forum topic proposal. Department of Health's Ministerial Industry Strategy Group, 2009. http://www.mhra.gov.uk/home/groups/es-policy/documents/websiteresources/con2030475.pdf. Accessed in September 30th, 2013.
    • (2009)
  • 38
    • 84897512938 scopus 로고    scopus 로고
    • Position Paper sui Farmaci Biosimilari. Agenzia Italiana del Farmaco, Accessed in October 1st, 2013
    • Position Paper sui Farmaci Biosimilari. Agenzia Italiana del Farmaco, 2013. http://www.agenziafarmaco.gov.it/sites/de fault/files/AIFA_POSITION_PAPER_FARMACI_BIOSIMILARI. pdf. Accessed in October 1st, 2013.
    • (2013)
  • 39
    • 84897519595 scopus 로고    scopus 로고
    • Policy statements: biosimilar medicines. Scottish Medicines Consortium, Accessed in October 2nd 2013
    • Policy statements: biosimilar medicines. Scottish Medicines Consortium, 2011. http://www.scottishmedicines.org.uk/About_SMC/Policy_Statements/Biosimilar_Medicines. Accessed in October 2nd 2013.
    • (2011)
  • 41
    • 84897540834 scopus 로고    scopus 로고
    • Public policy statement: biosimilars. Merck Sharp & Dohme, June, Accessed in September 30th, 2013
    • Public policy statement: biosimilars. Merck Sharp & Dohme, June 2010. http://www.merck.com/about/views-and- -positions/merck_biosimilars_public_policy2010.pdf. Accessed in September 30th, 2013.
    • (2010)
  • 42
    • 84897542091 scopus 로고    scopus 로고
    • Eli Lilly and Company, December 2012. Accessed in September 28th, 2013
    • Biosimilars and patient safety. Eli Lilly and Company, December 2012. Accessed in September 28th, 2013.
    • Biosimilars and patient safety.
  • 43
    • 84897488255 scopus 로고    scopus 로고
    • Roche: an innovator's perspective and position on biosimilars. Roche, September, Accessed in September 29th, 2013
    • Roche: an innovator's perspective and position on biosimilars. Roche, September 2010. http://www.roche.com/irp101005.pdf. Accessed in September 29th, 2013.
    • (2010)
  • 44
    • 84897535994 scopus 로고    scopus 로고
    • Our Global Position Statement on Biosimilars. Brystol Meyers Squibb, Accessed in October 1st, 2013
    • Our Global Position Statement on Biosimilars. Brystol Meyers Squibb, 2013. http://www.bms.com/responsibility/key_issues/Pages/Biosimilars.aspx. Accessed in October 1st, 2013.
    • (2013)


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