Physicians prefer greater detail in the biosimilar label (SmPC) - Results of a survey across seven European countries

Regulatory Toxicology and Pharmacology

Volumn 77, Issue , 2016, Pages 275-281

  Hallersten, Anna ^a   Fürst, Walter ^a   Mezzasalma, Riccardo ^b  

^a SFL Regulatory Affairs and Scientific Communication Ltd   (Switzerland)

^b The European Association for Bioindustries   (Belgium)

Author keywords

Biosimilars; Labelling survey; Physician preference; Regulatory requirements

Indexed keywords

BIOSIMILAR AGENT;

ARTICLE; CONTROLLED STUDY; FRANCE; GERMANY; HEALTH SURVEY; HUMAN; INFORMATION PROCESSING; ITALY; PHYSICIAN ATTITUDE; PHYSICIAN PREFERENCE; POLAND; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; SPAIN; SWEDEN; UNITED KINGDOM; CLINICAL TRIAL; DRUG CONTROL; DRUG INFORMATION; DRUG LABELING; EUROPE; GOVERNMENT REGULATION; HEALTH PERSONNEL ATTITUDE; INFORMATION DISSEMINATION; LEGISLATION AND JURISPRUDENCE; MULTICENTER STUDY; PHYSICIAN; PSYCHOLOGY; QUESTIONNAIRE;

ATTITUDE OF HEALTH PERSONNEL; BIOSIMILAR PHARMACEUTICALS; DRUG AND NARCOTIC CONTROL; DRUG INFORMATION SERVICES; DRUG LABELING; EUROPE; GOVERNMENT REGULATION; HUMANS; INFORMATION DISSEMINATION; PHYSICIANS; SURVEYS AND QUESTIONNAIRES;

EID: 84962773248     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2016.03.021     Document Type: Article

References (15)

1. Alliance for Safe Biologic Medicines (ASBM) ASBM 2013 European Prescriber Survey 2013, Brussels, Belgium, (last accessed 08.06.15.). http://safebiologics.org/resources/wp-content/uploads/2014/03/ASBM-EuropeanSurvey-Brussels-FINAL.pdf.
2. Alliance for Safe Biologic Medicines (ASBM) ASBM Labeling Survey 2015 2015, (last accessed 08.06.15.). http://safebiologics.org/resources/wp-content/uploads/2015/03/February-2015-Labeling-Report.pdf.
3. Committee for Medicinal Products for Human Use (CHMP) Guideline on Similar Biological Medicinal Products 2014, London, UK, (last accessed 08.06.15.). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf.
4. Dolinar R.O., Reilly M.S. Biosimilars naming, label transparency and authority of choice - survey findings among European physicians. Generics Biosimilars Initiative J. (GaBI Journal) 2014, 3:58-62.
5. European Commission A Guideline on Summary of Product Characteristics (SmPC) 2009, Brussels, Belgium, (last accessed 29.05.15.). http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf.
6. European Commission DG Enterprise What Do You Need to Know about Biosimilar Medicinal Products, Process on Corporate Responsibility in the Field of Pharmaceuticals Access to Medicines in Europe, a Consensus Information Document 2013, Brussels, Belgium, (last accessed 22.09.15.). http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/en/renditions/native.
7. European Medicines Agency (EMA) QRD General Principles Regarding the SmPC Information for a Generic/hybrid/biosimilar Product, EMA/627621/2011 2012, London, UK, (last accessed 29.05.15.). http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/05/WC500127589.pdf.
8. European Medicines Agency EMA Public Assessment Reports Website 2015, London, UK, (last accessed 08.06.15.). http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124.
9. European Parliament and the Council of the European Union Directive 2001/83/EC of the European Parliament and of the Council of November 2001 on the Community Code Relating to Medicinal Products for Human Use (Consolidated Version) 2012, Brussels, Belgium, (last accessed 08.06.15.). http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02001L0083-20121116&qid=1432823249171&from=EN.
10. Food and Drugs Administration (FDA) FDA News Release: FDA Approves First Biosimilar Product Zarxio 2015, Washington, USA, (last accessed 08.06.15.). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm.
11. Generics and Biosimilars Initiative Online (GaBI) Biosimilars Approved in Europe 2016, Mol, Belgium, (last accessed 09.02.16). http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe.
12. National Medical Products Register FASS - the Swedish Medicines Information Engine 2008, Stockholm, Sweden, (last accessed 08.06.15.). http://service.lif.se/default.aspx?id=31983.
13. Schneider C.K., et al. Setting the stage for biosimilar monoclonal antibodies. Nat. Biotechnol. 2012, 30:1179-1185.
14. Watson K., et al. A visible difference: clinical packaging WorldPharma - World Pharma Frontiers, (last accessed 08.08.15.). http://www.worldpharmaceuticals.net/features/featurea-visible-difference-clinical-packaging-4627678/.
15. Weise M., et al. Biosimilars - why terminology matters. Nat. Biotechnol. 2011, 29:690-693.