Current Issues of Therapy with Monoclonal Antibodies

• Autorzy: Karin Jahnz-Różyk
• Języki publikacji: EN

Abstrakty

EN

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

EN

Medications; Medicine

PL

Leki; Medycyna

• Czasopismo: Journal of Health Policy and Outcomes Research
• Rocznik: 2014
• Numer: nr 1
• Strony: 4--11

Twórcy

autor

Karin Jahnz-Różyk

• 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]

Identyfikatory

DOI

10.7365/JHPOR.2014.5.1