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有一个问题想请教： 一些已在FDA上市的生物药品，如Enbrel、Aranesp、Avastin在drugs@FDA中都有收载，并且there are no Therapeutic Equivalents”。 FDA“橙皮书”药品名单由“FDA生物制品评审和研究中心管理的药品”等四部分组成。 由此理解上述三个生物药应该都属于FDA生物制品评审和研究中心管理，也都应该列入橙皮书的，为什么会检索不到了？ FDA有在其他地方收载这些上市的专利生物药的专利情况吗？ 谢谢！ 1－orange book＝Approved Drug Products with Therapeutic Equivalence Evaluations； 就是说，美国的橙皮书指得是《经过治疗等效评价的已经批准药品集》。 也就是说，orange book包含的产品是经过治疗等效性评价的，而且收入橙皮书的药品是根据Food, Drug and Cosmetic Act批准的，而生物制品是根据Public Health Service Act批准的。在Hatch-Waxman Act （美国的仿制药促进法案）没有为根据Public Health Service Act批准的生物制品设定仿制的途径。 2－你提到的3个产品属于生物制品，但是需要注意，美国对于生物制品的管理，由CBER和CDER两个中心一起管理。 下面是他们分别的管理范围： Categories of Therapeutic Biological Products Transferred to CDER Monoclonal antibodies for in vivo use. Proteins intended for therapeutic use, including cytokines (e.g. interferons), enzymes (e.g. thrombolytics), and other novel proteins, except for those that are specifically assigned to CBER (e.g., vaccines and blood products). This category includes therapeutic proteins derived from plants, animals, or microorganisms, and recombinant versions of these products. Immunomodulators (non-vaccine and non-allergenic products intended to treat disease by inhibiting or modifying a pre-existing immune response). Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo.1 Categories of Therapeutic Biological Products Remaining in CBER Cellular products, including products composed of human, bacterial or animal cells (such as pancreatic islet cells for transplantation), or from physical parts of those cells (such as whole cells, cell fragments, or other components intended for use as preventative or therapeutic vaccines). Gene therapy products. Human gene therapy/gene transfer is the administration of nucleic acids, viruses, or genetically engineered microorganisms that mediate their effect by transcription and/or translation of the transferred genetic material, and/or by integrating into the host genome. Cells may be modified in these ways ex vivo for subsequent administration to the recipient, or altered in vivo by gene therapy products administered directly to the recipient. Vaccines (products intended to induce or increase an antigen specific immune response for prophylactic or therapeutic immunization, regardless of the composition or method of manufacture). Allergenic extracts used for the diagnosis and treatment of allergic diseases and allergen patch tests. Antitoxins, antivenins, and venoms Blood, blood components, plasma derived products (for example, albumin, immunoglobulins, clotting factors, fibrin sealants, proteinase inhibitors), including recombinant and transgenic versions of plasma derivatives, (for example clotting factors), blood substitutes, plasma volume expanders, human or animal polyclonal antibody preparations including radiolabeled or conjugated forms, and certain fibrinolytics 另外，在2003年6月30日，FDA将一批生物制品由CBER管理移交CDER管理，你的这3个产品正好在这个范围内。 下面是移交的名单。 http://www./cber/transfer/transfprods.htm 3－下面分别是CDER药品查询连接和CBER生物制品查询连接。 CBER provides a list of currently approved biologics: http://www./cber/ep/part3.htm CDER provides a means to find drugs it regulates: http://www.accessdata./scripts/cder/drugsatfda/index.cfm 4－到目前为止，生物制品没有仿制药的概念。 因为即使是原研公司在另外一个地方按照自己的生产工艺生产的生物制品，也是不能证明生物等效的。因为美国FDA不称 ‘generic’ biologic “，而称 ‘follow-on’ biologic。 5－目前有消息，据说FDA在起草法规和指南，为生物制品的仿制开辟道路。但是目前为止，据我所知，还没有放下第一块砖头。 |
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来自： 一土山人 > 《Pharmaceutical》
