The Approval Process for Biosimilar Erythropoiesis-Stimulating Agents
نویسندگان
چکیده
منابع مشابه
The approval process for biosimilar erythropoiesis-stimulating agents.
A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage ...
متن کاملBiosimilar agents in oncology/haematology: from approval to practice
The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors hav...
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Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other problems related to medical products after they have been licensed for marketing. The purpose of PV is to advance the safe use of marketed medical products. Regulatory agencies and license holders collaborate to collect data reported by health car...
متن کاملErythropoiesis stimulating agents: a personal journey.
I write this editorial in deference to the many experts who devote their careers to this important field. In this editorial, I simply report the journeyman route of a medical oncologist who is desperately trying to improve the outcomes of women suffering from breast cancer. At the end of the 1990s, there was much hope that erythropoie-sis stimulating agents (ESAs) would improve the survival of ...
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Recombinant human erythropoietin (rHuEPO), such as the approved agents epoetin alfa and epoetin beta, has been used successfully for over 20 years to treat anemia in millions of patients. However, due to the relatively short half-life of the molecule (approximately 8 hours), frequent dosing may be required to achieve required hemoglobin levels. Therefore, a need was identified in some anemic pa...
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ژورنال
عنوان ژورنال: Clinical Journal of the American Society of Nephrology
سال: 2014
ISSN: 1555-9041,1555-905X
DOI: 10.2215/cjn.01770214