BIOPHARMACEUTICAL DRUGS: THE PROBLEM OF SAFETY
Abstract
In the article the peculiarities of bio-similar drugs marketing and registration, the problems of biopharmaceuticals use safety are studied.
Keywords:
bio-similar drugs, biopharmaceutical agents, bio-similar handling regulationReferences
1. Kolbin A.S. What does we wait from an innovative drug? The clinical pharmacology view. In Adam Smith Conferences› 2nd International Forum Innovative Drug Research and Development in Russia, Moscow, 21-22.11.2011.
2. Ишмухаметов А.А. Инновационные лекарственные препараты: перспективы терапии тяжелых заболеваний. // Ремедиум – 2011 - № 5.
3. www.healtheconomics.ru
4. www.datamonitor.com
5. Article 10 (2) b of Directive 2001/83 as amended
6. HIS Global insight Article, 06 March 2009; http://www.ibclifesciences.com/upload/wysiwyg/biopharma_series/B9194 /BiosimilarsUS_IHSGlobalInsight.pdf
7. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues”, EMEA/CHMP/49348/05.
8. European Union: 26 May 2006: Generics Industry Leader Warns of Stumbling Blocks to European Biosimilars Market.
