Warianty tytułu
Języki publikacji
Abstrakty
The paper presents the most important aspects of treatment with monoclonal antibodies (MABs). Clinical and economic consequences of MABs biosimilars were shown. Access to MABs treatment in drug programs in Poland has been also presented(original abstract)
Słowa kluczowe
Rocznik
Numer
Strony
4--11
Opis fizyczny
Twórcy
autor
- Department of Immunology and Clinical Allergology, Military Institute of Medicine in Warsaw, Poland
Bibliografia
- National Institute for Bioprocessing Research and Training, 25th April 2014
- Drug programs. Available from: www.mz.gov.pl; [Accesed: 20.07.2014]
- Hansel TT., Kropshofer H., Singer T., Mitchel AJ, Gerge T: The safety and side effects of monoclonal antibodies. Nature Reviews Drug Discovery, 2010; 9: 325 -338
- De Silva S., Smith A., Bending M. Insight into HTA Decision Making behind the EU,s Current crop of Biosimilars, ISPOR Connections, 2014; 20,2: 7-9
- Guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: quality issues (revision 1), Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf; [Accesed: 20.07.2014]
- Lucio SD., Stevenson JG., Hoffman JM. Biosimilars: Implications for health system pharmacists. Am J Health-Syst Pharm, 2013; 70:2014-17
- Calvo B., Zuńiga L. Therapeutic Monoclonal Antibodies: Strategies and Challenges for Biosimilars Development, Current Medicinal Chemistry, 2012; 19: 4445-4450
- Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J Oct 11 2013. Available from: http://dx.doi.org/10.1208/s12248-013-9534-y; [Accesed: 20.07.2014]
- Casadevall N., Edwards IR., Felix T., Graze PR., Bruce JB., Strober E. & David G Warnock. Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert Opin Biol Ther, 2013; 13, 7: 1039-1047
- Sands A. Top patent losses to watch out for Manufacturing, Pricing & Market Access. Available from: http://www.totalbiopharma.com/wp-content/uploads/sites/7/2014/01/0-Total-Biopharma-2014-Blog-Banner-960-220.png; [Accesed: 20.07.2014]
Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
bwmeta1.element.ekon-element-000171463144