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有一個(gè)問題想請教： 一些已在FDA上市的生物藥品，如Enbrel、Aranesp、Avastin在drugs@FDA中都有收載，并且there are no Therapeutic Equivalents”。 FDA“橙皮書”藥品名單由“FDA生物制品評審和研究中心管理的藥品”等四部分組成。 由此理解上述三個(gè)生物藥應(yīng)該都屬于FDA生物制品評審和研究中心管理，也都應(yīng)該列入橙皮書的，為什么會(huì)檢索不到了？ FDA有在其他地方收載這些上市的專利生物藥的專利情況嗎？ 謝謝！ 1－orange book＝Approved Drug Products with Therapeutic Equivalence Evaluations； 就是說，美國的橙皮書指得是《經(jīng)過治療等效評價(jià)的已經(jīng)批準(zhǔn)藥品集》。 也就是說，orange book包含的產(chǎn)品是經(jīng)過治療等效性評價(jià)的，而且收入橙皮書的藥品是根據(jù)Food, Drug and Cosmetic Act批準(zhǔn)的，而生物制品是根據(jù)Public Health Service Act批準(zhǔn)的。在Hatch-Waxman Act （美國的仿制藥促進(jìn)法案）沒有為根據(jù)Public Health Service Act批準(zhǔn)的生物制品設(shè)定仿制的途徑。 2－你提到的3個(gè)產(chǎn)品屬于生物制品，但是需要注意，美國對于生物制品的管理，由CBER和CDER兩個(gè)中心一起管理。 下面是他們分別的管理范圍： 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，F(xiàn)DA將一批生物制品由CBER管理移交CDER管理，你的這3個(gè)產(chǎn)品正好在這個(gè)范圍內(nèi)。 下面是移交的名單。 http://www./cber/transfer/transfprods.htm 3－下面分別是CDER藥品查詢連接和CBER生物制品查詢連接。 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－到目前為止，生物制品沒有仿制藥的概念。 因?yàn)榧词故窃泄驹诹硗庖粋€(gè)地方按照自己的生產(chǎn)工藝生產(chǎn)的生物制品，也是不能證明生物等效的。因?yàn)槊绹鳩DA不稱 ‘generic’ biologic “，而稱 ‘follow-on’ biologic。 5－目前有消息，據(jù)說FDA在起草法規(guī)和指南，為生物制品的仿制開辟道路。但是目前為止，據(jù)我所知，還沒有放下第一塊磚頭。 |
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