Czasopismo
Tytuł artykułu
Warianty tytułu
Języki publikacji
Abstrakty
The first biological therapeutics have already reached their patent expiration dates and corresponding biosimilars have been approved by the EMA and FDA. The approval of products similar, but not identical to already known innovative biologics is stirring a lot of debate about safety concerns, as well as the relevance of these differences to clinical practice. A Group of 13 experts involved in various aspects of biological therapies in Poland was established. Modified Delphi method of voting was performed to achieve consensus regarding the most important aspects of biological treatment in Poland, with particular concern regarding biosimilars. Ten final statements were discussed and voted upon. The statements cover general aspects of biosimilars, including expected cost-benefit ratios, extrapolation of clinical indications, interchange, switching, patient information and the requirement of patient consent. The state of post-marketing pharmacovigilance of biologicals (innovative ones as well as biosimilars) was also discussed(original abstract)
Rocznik
Numer
Strony
58--65
Opis fizyczny
Twórcy
autor
- Military Institute of Medicine in Warsaw, Poland
- Institute of Rheumatology in Warsaw, Poland
autor
- Military Institute of Medicine in Warsaw, Poland
autor
- Mossakowski Medical Research Centre of the Polish Academy of Sciences in Warsaw, Poland
autor
- Medical University of Warsaw in Warsaw, Poland
autor
- Military Institute of Medicine in Warsaw, Poland
autor
- Military Institute of Medicine in Warsaw, Poland
autor
- Institute of Rheumatology in Warsaw, Poland
autor
- Central Clinical Hospital of theMinistry of Interior in Warsaw, Jan Kochanowski University in Kielce, Poland
autor
- Independent Public Clinical Hospital of Ophthalmology in Warsaw, Poland
autor
- Maria Skłodowska-Curie Institute of Oncology in Warsaw, Poland
autor
- ndependent Public Clinical Hospital of Ophthalmology in Warsaw, Poland
Bibliografia
- Abreu MM., Strand V., Levy RA., Araujo DV. Putting the value into biosimilar decision making. The judgment value criteria. Autoimmunity Rev. 2014; 13: 678-684
- Argüelles-Arias F., Barreiro-de-Acosta M., Carballo F., et al. 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(1): 37-43
- Clin. Trials.gov. An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1 NCT01571219
- Clin.trials.gov. An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1 NCT01571206
- 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(7): 586-589
- Dixon WG., Carmona L., Finckh A., et al. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. Ann Rheum Dis, 2010; 69(9): 1596-1602
- Dörner T., Strand V., Castañeda-Hernández G. et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis, 2013; 72(3): 322-328
- Elkayam O., Pavelka K. Biologic registries in rheumatology: lessons learned and expectations for the future. Autoimmun Rev. 2012; 12(2): 329-336
- Engelberg AB., Kesselheim AS., Avorn J. Balancing innovation, access, and profits--market exclusivity for biologics. N Engl J Med. 2009; 361(20): 1917-1919
- European Medicines Agency Guideline on similar biological medicinal products. 22 May 2013 CHMP/437/04 Rev 1 Committee for Medicinal Products for Human Use (CHMP) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf; [Accessed: 10.05.2014]
- European Medicines Agency. Questions and answers on biosimilar medicines. http://www.ema.europa.eu/docs/ en_GB/document library/Medicine_QA27SEP2012 EMA/837805/2011; [Accessed: 10.05.2014]
- Fiorino G., Girolomoni G., Lapadula G. et al.: on behalf of SIR, SIDeMaST, and IG-IBD. The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev. 2014; 13(7): 751-755
- Kucharz EJ. Reumatolog na rozdrożu, czyli o biologicznych lekach biopodobnych [Rheumatologist at the crossroads - about biosimilar biological medicines]. Reumatologia 2014; 52(1): 86-88
- Kurki P., Bielsky MC. Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) of Committee for Medicinal Products for Human Use (CHMP). ECCO position challenged by European drug regulators. J Crohns Colitis. 2014; 8(3): 258
- Lee H., Yim DS., Zhou H., Peck CC. Evidence of effectiveness: how much can we extrapolate from existing studies? AAPS J. 2005; 5; 7(2): E467-74
- Mularczyk A., Gonciarz M., Bartnik W. et al. Biosimilar medicines - their use in the treatment of inflammatory bowel diseases. Position statement of the Working Group of the Polish National Consultant in Gastroenterology. Special paper. Prz Gastroenterol 2014; 9(1), 1-3
- Munsch J. Biosimilars: new promise for reducing healthcare costs. J Biomed Res. 2014; 28(2): 75-77
- Nam JL., Ramiro S., Gaujoux-Viala C. et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2014; 73(3): 516-28
- Ramiro S., Gaujoux-Viala C., Nam JL. et al. Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2014; 73(3): 529-535
- Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013; 72: 315-318
- Smolen JS., Landewé R., Breedveld FC. et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014; 73(3): 492-509
- Ventola C. Biosimilars Part 1: Proposed Regulatory Criteria for FDA Approval. P T 2013; 38: 270-277
- Weise M., Bielsky MC., De Smet K., Ehmann F., Ekman N., Giezen TJ., Gravanis I., Heim HK., Heinonen E., Ho K., Moreau A., Narayanan G., Kruse NA., Reichmann G., Thorpe R., van Aerts L., Vleminckx C., Wadhwa M., Schneider CK. Biosimilars: what clinicians should know. Blood. 2012; 20; 120(26): 5111-5117
- Zink A., Askling J., Dixon WG., Klareskog L., Silman AJ., Symmons DP. European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis. 2009; 68(8): 1240-1246
Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
bwmeta1.element.ekon-element-000171463969
JavaScript jest wyłączony w Twojej przeglądarce internetowej. Włącz go, a następnie odśwież stronę, aby móc w pełni z niej korzystać.