Editor-in-Chief
Hatice Kübra Elçioğlu
Vice Editors
Levent Kabasakal
Esra Tatar
Online ISSN
2630-6344
Publisher
Marmara University
Frequency
Bimonthly (Six issues / year)
Abbreviation
J.Res.Pharm.
Former Name
Marmara Pharmaceutical Journal
Marmara Pharmaceutical Journal
2015 , Vol 19 , Issue 3
Biosimilar products: Definitions and registration process
1Marmara Üniversitesi, Eczacılık Fakültesi, Farmasötik Biyoteknoloji Anabilim Dalı, 34668, Haydarpaşa, İstanbul, Türkiye2Marmara Üniversitesi, Eczacılık Fakültesi, Farmasötik Biyoteknoloji Anabilim Dalı, 34668, Haydarpaşa, İstanbul, Türkiye DOI : 10.12991/mpj.20151970579 With the developments in recombinant DNA and hybridoma technology, biological products are being used for the treatment of many diseases especially in irreversible diseases and improving the quality of life of patients. After the expiry of the patent of approved biologics, biosimilar products are being produced, registered and launched in markets.
In scope of this review, the status of biological and bio similar products in global markets and Turkey were evaluated along with the definitions given by FDA, EMA and Turkish Drug and Medical Device Institution and explanation of the differences of biological products compared to conventional medicines and their evaluation parameters as bio similar products are not accepted as bio equivalent same as the conventional medicines.
Keywords : Biological product, biotechnological product, biosimilar product, recombinant DNA technology, EMA, FDA