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本帖最后由 aiyao 于 2016-4-18 02:18 PM 编辑 % H+ f, ?" m5 P/ |. k: B" \
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来源;网络汇总 * [4 r8 a7 Q9 R0 O) L, a( [! S9 w
美国食品和药物管理局（FDA）周四发布了38种仿制药的生物等效性试验，为仿制药企业为获得批准而提交的简化新药申请（ANDA）提出具体建议。 这个列表的目的是列出通过什么样的试验来开发仿制药，虽然其中的一些抗肿瘤用药，有的还没有失去专利保护，而有的则在最近获得批准，比如，辉瑞公司的治疗乳腺癌新药Ibrance（palbociclib），卫材的甲状腺癌药物Lenvima（lenvatinib甲磺酸）和诺华的基底细胞癌的治疗Odomzo（sonidegib磷酸盐）。 * X& y1 C- n: A5 N, i# P' z' s' B
在决定发布哪些指导性文件时，仿制药的FDA的仿制药办公室（OGD）在周三发布的一份报告称，它认为制剂的复杂性，能够准确测量在作用部位的生物利用度，用科学方法来证明生物等效性和以前的经验和同类药物的知识。 6 P& p' c3 h0 v% n3 h8 b
OGD还考虑到对这些指导性文件的需要有多大。通过对此类文件的请求的数量，并通过分析评估100种最畅销的药物和其他广泛使用的药物的清单来得到需求的程度。
+ o" T1 ] z; a4 `% F t. k它还涉及到一些新的指导意见，特别是对诺华重磅炸弹心脏衰竭治疗Entresto（sacubitril /缬沙坦）和Vertex的昂贵的治疗囊性纤维化Kalydeco（ivacaftor）的仿制药。
) |, A+ K: L* u- \7 e2 a38种仿制药生物等效性性试验建议 （RLD：ReferenceListed Drug） | 活性物质 | | | | | | | | | | | | | | | | | | | | | | | | 扑尔敏polistirex;可待因polistirex | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 061904
- |$ ]! |6 H& t/ _# ~ 061905 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
其他具体的指导性文件包括：扬森公司的抗HIV药物Prezcobix的仿制药（Cobicistat;地瑞那韦乙醇），礼来公司的2型糖尿病用药Glyxambi（恩格列净/利拉利汀）和施贵宝公司丙型肝炎用药Daklinza（daclatasvir二盐酸盐）。 7 k2 s: V. k& [2 b2 W1 F6 h2 P
“要成功开发和生产仿制药产品，申请人应当考虑他们的产品预计将：药学相当于其参考上市药品（RLD），即具有相同的活性成分，剂型，强度和给药路径在相同条件下施用，与RLD生物等效，也就是说，显示在速率和药物活性成分的吸收程度无显著差异;以及，在治疗上等同，即，可取代RLD，期望的通用产品与RLD具有相同的安全性和有效性，“FDA表示。 & v0 R, h! e9 O" a6 V3 p% u
“为了进一步促进仿制药产品的可获得性，并协助仿制药行业确定最适当的方法为开发药物并产生支持ANDA批准所需要的证据，FDA发布了特定产品的建议，描述了如何开发通用药的目前的想法和期望药品在治疗上等同于具体参照上市RLD的药品，“FDA说。 * ~; l* S/ J: ]: n& W7 y/ {
更新后的指南包括环丙沙星/地塞米松，环孢素，睾酮，替卡格雷和缬更昔洛韦盐酸等6种修订后的生物等效性建议。 具体FDA网站请单击原文链接（英文）。 FDA Provides Generic Approval Roadmap for 38 Drugs,Including Vertex's Kaldeco9 i7 T$ o' l% n- p3 ?& `2 T
[size=0.875]The US Food and Drug Administration (FDA) has announcedthe release of newdocuments meant to make it easier for generic manufacturers to introducecompetition to 38 existing drug products, including popular new drugs likeStendra, Belviq, Kalydeco and Brilinta. [size=0.875]The documents, known as bioequivalencerecommendations, specifically apply to the Abbreviated New Drug Application(ANDA) process—the process by which generic drugs are approved. [size=0.875]Generic drugs, unlike new drugs, may beapproved by FDA by showing that they are (among other things) bioequivalent tothe drug they intend to reference. Bioequivalence can be shown in relativelysmall trials involving human subjects, which permits a company to avoid muchlarger—and much more expensive—full clinical trials required of new drugsubstances. [size=0.875]The bioequivalence guidance documents releasedby FDA last week explain how each generic drug company can test its products toensure they pass FDA muster. Each document contains a list of recommendedstudies (typically at least two), the characteristics of each study, thestandard for bioequivalence that must be met by each generic product andpotential waivers a generic company may apply for. [size=0.875]The documents are, in effect, a roadmap forregulatory approval for generic drug companies. The publication of abioequivalence document does not, however, indicate that FDA will approve ageneric drug product immediately. Patent and marketing exclusivity protections maystill be in effect, which can preclude FDA approval or market access. NewBioequivalence Guidance Documents[size=0.875]The new documents, along with a list of thebrand name drugs they reference, are as follows: | | | | | | | Tablet | | Stendra | Vivus | | | Tablet 0 R9 N, O D z$ {' v
[size=0.875]Capsule | | Edarbyclor | Arbor Pharmaceuticals | | | Film | | Bunavail | Biodevlivery Sciences | | | Tablet | | Advil Allergy and Congestion Relief | Pfizer | | | Capsule | | Sandimmune | Novartis | | | Capsule (modified) | | Neoral | Novartis | | | Tablet | | Ferriprox | ApoPhrarma | | | Spray | | Topicort | Taro | | | Capsule | | Zorvolex | Iroko Pharmaceuticals | | / B! M# Y; W+ t& i+ c
| Tablet | | Aleve PM | Bayer Healthcare | | | Solution/drops | | Trusopt | Merck | | | Capsule | | | Par Pharmaceuticals | | | Tablet | | Complera | Gilead Sciences | | | Cream | | Tri-Luma | Galderma Labs | | 0 W; K F8 Q. j7 s( [: \ X
| Capsule | | Imbruvica | Pharmacylics | | | Capsule | | Advil Liqui-Gels | Pfizer | | | Aerosol, metered | | Atrovent HFA | Boehringer Ingelheim | | | Tablet | | Isordil | Valeant Bermuda | | | Tablet | | | Par Pharmaceuticals | | | Capsule | | Absorica | Ranbaxy | | | Tablet | | Kalydeco | Vertex | | | Tablet, Chewable | | Imodium A-D EZ Chews | McNeil Consumer Healthcare | | | Capsule | | | Banner Life Sciences | | | Capsule | | Imodium | McNeil Consumer Healthcare | | | Suspension | | Imodium A-D | McNeil Consumer Healthcare | | | Tablet | | Imodium A-D | McNeil Consumer Healthcare | | | Tablet | | Belviq | Eisai | | | Powder, Extended Release | | Arestin | Orapharma | | | Tablet | | | Vintage Pharmaceuticals | |
( L5 U2 K) F0 J [size=0.875] | Tablet, Extended Release | | K-Tab | Abbvie | | | Tablet | | Biltricide | Bayer | | | Tablet | | Darprim | Amedra | | | Powder | | Kayexalate | Covis Pharmaceuticals | | 8 ?1 H$ O4 Y- I8 h0 x
[size=0.875] | Tablet, Chewable | | Velphoro | Vifor Fresenius | | | Tablet | | Brilinta | AstraZeneca | | | Capsule, Extended Release | | Qudexy XR | Upsher Smith | | | Capsule, Extended Release | | Trokendi XR | Supernus Pharmaceuticals | | | Tablet | | Sabril | Lundbeck |
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