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KMID : 1142220070020020029
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Regulatory Research on Food, Drug & Cosmetic
2007 Volume.2 No. 2 p.29 ~ p.38
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Developments and Regulatory Aspects of Similar Biological Medicinal Products
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Lee Seok-Ho
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Abstract
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Whether or not generic versions of biological medicines are allowed has been at the center of serious debates for some years. EMEA appears to be the first to have set up a systematic regulatory p10rocedure regarding the licensing of generic version of biological medicinal products, although corresponding guidance appears to be almost ready at the U.S. FDA also; i.e., similar biological medicinal products or biosimilar products. Unlike small molecule chemical drugs, the developers (sponsors) of biosimilar products are required to do their best to prove similarity (comparability) of their products with the originator’s reference products. At the U.S. FDA, some biologics were transferred from CBER to CDER several years ago, due to political reasons. This has made the regulatory processes depend on either of the two acts such as the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, which makes drug sponsors developing both brand-new biologics and follow-on products even more confused. In Korea, the generic versions of biologics are reviewed under ‘the others’ in the related Provision on Biologics Review and Approval. Although novel new biologics should definitely provide the sponsors their edge in the market, the future of the improved versions of biosimilar products is believed to be bright as well.
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KEYWORD
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Biosimilar product, Biosmilar product, biologics, product development, product regulation
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FullTexts / Linksout information
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Listed journal information
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