Biosimilars: State of Clinical and Regulatory Science
نویسندگان
چکیده
منابع مشابه
The 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...
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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...
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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...
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...
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Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source pro...
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ژورنال
عنوان ژورنال: Journal of Pharmacy & Pharmaceutical Sciences
سال: 2017
ISSN: 1482-1826,1482-1826
DOI: 10.18433/j3vk90