579P Methodological considerations for clinical equivalence of bevacizumab biosimilars
نویسندگان
چکیده
منابع مشابه
Clinical 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...
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Biosimilars of biologics used for cancer treatment and supportive care are expected to enter the U.S. market soon. Biosimilars will be highly similar to their reference products, but unlike generic drugs, not identical. Differences between a biosimilar and its reference product may arise because of the complexity of biologics, and differences in the cell lines and processes used during manufact...
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BACKGROUND Laboratory testing in clinical practice is never a random process. In this study we evaluated testing bias for neutrophil counts in clinical practice by using results from requested and non-requested hematological blood tests. METHODS This study was conducted using data from the Utrecht Patient Oriented Database. This clinical database is unique, as it contains physician requested ...
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Cancer is a debilitating disease affecting millions of people daily. Over the years, cancer treatment has advanced in leaps and bounds. Antibodies are important breakthrough therapeutic agents for cancer. These agents, proteins produced by B lymphocytes of the immune system in response to antigens, bind to receptors on cell surfaces so that the antigen-antibody complexes can be recognized and d...
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The global development of a biosimilar product is a methodologically complex affair, lined with potential design pitfalls and operational missteps to be avoided. Without careful attention to experimental design and meticulous execution, a development programme may fail to demonstrate equivalence, as would be anticipated for a biosimilar product, and not receive regulatory approval based on curr...
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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2016
ISSN: 0923-7534
DOI: 10.1016/s0923-7534(21)00737-7