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New Paradigm of Biological Products and Harmonization of the Abbreviated Licensing Pathway for Biological Products

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The term 'generic' drug is used for chemical drug that are structurally and therapeutically equivalent to an originator product and a regulatory pathway for its approval has been established. However a variety of terms such as 'similar biological medicinal products(biosimilars)', 'follow-on protein products', 'biogenerics', and 'subsequent entry biologics' have been used by different country or region about biological product. And the approach established for small molecule generic product is not appropriate for development, evaluation and licensing of subsequent entry biological product. Because biological product is large and highly complex
molecule that are difficult to characterized. Also structure of the biological product is generally very sensitive to various production parameters such as media, temperature, scale so that it is unlikely that one manufacturer will be able to reproduce biological product manufactured by another company. On the other hand, biological products have been important to treatment of many life-threatening and chronic diseases such as cancer, chronic renal failure, diabetes mellitus. However, there has been a problem with limiting their access to patients because of relatively high cost. Recently the expiration of patents and data protection for the first major group of
innovative biological products that were licensed based on full registration dossier is ushering in an era of subsequent entry biological products. For this reason, subsequent entry biological products are increasingly widen their range and are needed overall regulation and guideline for their evaluation. Therefore KFDA go forward
with preparing the guideline for subsequent entry biological products and harmonize international guideline with it.

저자정보

  • Kyung Tak NAM Recombinant Products Division, KFDA

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