Editor-in-Chief İlkay Küçükgüzel Associate Editor Aslı Türe Online ISSN 2630-6344 Publisher Marmara University Frequency Bimonthly (Six issues / year) Abbreviation J.Res.Pharm. Former Name Marmara Pharmaceutical Journal
Marmara Pharmaceutical Journal 2016 , Vol 20 , Issue 1
Potential problems of biosimilars in clinical practice
Fatma Ceyda KORUCU4, Hakan NAZLI1, Gulsah GEDİK2, Irfan CICIN3
1Trakya Üniversitesi, Eczacılık Fakültesi, Farmasötik Teknoloji ABD, EDİRNE
2Trakya Üniversitesi, Eczacılık Fakültesi, Farmasötik Teknoloji ABD, EDİRNE
3Trakya Üniversitesi, Tıp Fakültesi, Medikal Onkoloji BD, EDİRNE
4Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi, EDİRNE
DOI : 10.12991/mpj.20164450877 Biopharmaceuticals are macro and complex medicines obtained from biological sources using biotechnology. In the production of biopharmaceuticals, due to the use of living organisms and the complex method of production, in different series made by the same manufacturer even consist differences. Thus different manufacturers can produce similar molecules to the originator, "biosimilar" definition is used to indicate these differences. Nowadays biosimilars are used in treatment of many diseases especially cancer, hematologic diseases and endocrine diseases. Using biosimilars in treatment more frequently and enalarge of their market share encourage to produce copies of patent expired products. The objective of studies in the licensing process is to show rather than to prove that biosimilars are better than their originator, in terms of structure, safety and efficiency. Immunogenicity is the biggest problem encountered in clinical practice for biopharmaceutical products and it may affect medicine activity and safety. In clinical practice, health authoritarian should establish well balance of costs, patient benefit, uncertainty. Keywords : Biopharmaceutics, Biosimilar pharmaceuticals, Immunogenicity, Clinical Practice
Marmara University