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 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: 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 کاملThe Science Behind Biosimilars
An important challenge currently facing rheumatologists and rheumatology health professionals is to gain an understanding of the landscape surrounding biosimilar agents, including the scientific, clinical, economic, and prescribing issues related to their use. The US Food and Drug Administration (FDA) defines a biosimilar as a biologic product that is “highly similar to” an approved biologic pr...
متن کاملThe protein science of biosimilars.
A sea change is occurring in the off-patent drug manufacturing industry with a first wave of biotechnologically derived products reaching the end of their patent lives. However, recombinant proteins are in a different league from their chemical predecessors in terms of molecular complexity. Small differences in manufacturing processes can affect the efficacy and safety of the recombinant protei...
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ژورنال
عنوان ژورنال: Blood
سال: 2014
ISSN: 0006-4971,1528-0020
DOI: 10.1182/blood-2014-06-583617