منابع مشابه
What Is a Generic Biopharmaceutical ? Biogeneric ? Follow - On Protein ? Biosimilar ? Follow - On Biologic ?
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The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimil...
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T he Chemistry, Manufacturing, and Controls (CMC) Strategy Forum held on 22 January 2012 in San Francisco, CA, focused on selected scientific and regulatory aspects in the development of biosimilar products. Such products are becoming an increasingly important area of interest for both the biopharmaceutical industry and regulatory agencies. Biosimilars are highly complex, and scientists have be...
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Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval framework for biosimilar products, and WHO has published guidelines on the evaluation of biosimilars ...
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Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments. Approval of a biosimilar product relies on the demonstration of "comparability" or "no clinically meaningful differences" as compared to its reference biologic ...
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ژورنال
عنوان ژورنال: Hospital Pharmacy
سال: 2012
ISSN: 0018-5787,1945-1253
DOI: 10.1310/hpj4711-822