Potential problems of biosimilars in clinical practice
Küçük Resim Yok
Tarih
2016
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Marmara Univ, Fac Pharmacy
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
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.
Açıklama
Anahtar Kelimeler
Biopharmaceutics, Biosimilar Pharmaceuticals, Immunogenicity, Clinical Practice, Non-Inferiority Trials, Immunogenicity
Kaynak
Marmara Pharmaceutical Journal
WoS Q Değeri
N/A
Scopus Q Değeri
N/A
Cilt
20
Sayı
1
