منابع مشابه
Pharmacovigilance 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 کاملComparative testing and pharmacovigilance of biosimilars.
Unlike traditional generic pharmaceuticals, biosimilars (also called 'follow-on biopharmaceuticals' in the USA) aim to copy a complex recombinant, three-dimensional protein structure with high molecular weight. Small changes in the manufacturing process can alter the product's effect and safety. According to the guidelines of the European Agency for the Evaluation of Medicinal products (EMEA), ...
متن کاملBiosimilars in oncology: current and future perspectives
The healthcare burden of cancer Cancer places a signifi cant, and growing, burden on healthcare systems around the world. Improved therapies and changing demographics are conspiring to increase the already considerable drain on resources. On the one hand, population growth and ageing will increase the number of new cancer cases in the coming years [1]; on the other, advances in diagnosis and ma...
متن کاملClinical considerations for the development of biosimilars in oncology
Despite availability of biologic therapies, limited patient access to many of the most-effective cancer treatments affects overall health outcomes. To address this issue, many governments have enacted legislation for the approval of biosimilars. The term "biosimilar" refers to a biologic product that is developed to be highly similar, as opposed to identical, to a licensed biologic product (the...
متن کاملBiosimilars in the United States: Considerations for Oncology Advanced Practitioners
Biosimilars will enter the US market soon, potentially lowering costs and increasing patient access to important oncology biologics. Biosimilars are highly similar, but not identical, to their reference product. Subtle variations arise due to their inherent complexity and differences in manufacturing. Biosimilars are not generic drugs. They will be approved through a separate US regulatory path...
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ژورنال
عنوان ژورنال: Journal of Pharmacovigilance
سال: 2016
ISSN: 2329-6887
DOI: 10.4172/2329-6887.s3-001