منابع مشابه
Biosimilars: the science of extrapolation.
Despite the establishment of a specific approval pathway, the issuance of detailed scientific guidelines for the development of similar biological medicinal products (so-called "biosimilars") and the approval of several biosimilars in the European Union, acceptance of biosimilars in the medical community continues to be low. This is especially true in therapeutic indications for which no specif...
متن کاملPharmacovigilance of Oncology Biosimilars
Biologicals are critical in cancer medicine. Four of the top ten biological blockbusters worldwide are oncology drugs used for therapeutic or supportive care. The global market for biologic cancer therapies approximately totalled US$ 51.2 billion in 2014 and is expected to reach US$ 66.4 billion in 2019. The patents of most of these top-selling agents will expire by the year 2020 attracting ind...
متن کاملBiosimilars: in support of extrapolation of indications.
Biosimilars have the potential to lead to enormous cost savings in healthcare without reducing the level of care for patients. In Europe, biosimilars have to demonstrate comparability in an extensive biosimilarity exercise including analytical, preclinical and comparative clinical studies. By successfully completing the biosimilarity exercise, the biosimilar shows that all aspects that are cons...
متن کاملPerspectives Biosimilars: the science of extrapolation
Since the establishment of a specific approval pathway for similar biological medicinal products, so-called “biosimilars,” several biosimilars have been licensed and become available in the European Union (EU). However, despite a stringent approval process, acceptance of biosimilars in the medical community continues to be low. This appears to be especially true for therapeutic indications, for...
متن کاملBiosimilars and the extrapolation of indications for inflammatory conditions
Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indication for the biosimilar product to all the indications originally approved for the originator. Reg...
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ژورنال
عنوان ژورنال: Critical Reviews in Oncology/Hematology
سال: 2016
ISSN: 1040-8428
DOI: 10.1016/j.critrevonc.2016.06.002