Brief introduction for application of USA authorized generic drugs

doi:10.5246/jcps.2019.06.043

Journal of Chinese Pharmaceutical Sciences ›› 2019, Vol. 28 ›› Issue (6): 439-445.DOI: 10.5246/jcps.2019.06.043

• Drug administration and clinical pharmacy column • Previous Articles Next Articles

Brief introduction for application of USA authorized generic drugs

Dongsheng Yang, Lingyun Ma, Jianzhao Niu, Mingdi Xu^*

National Institutes for Food and Drug Control, Beijing 100050, China

Received:2019-03-25 Revised:2019-04-16 Online:2019-06-30 Published:2019-04-29
Contact: Tel.: +86-13521033996, E-mail: yangdongsheng@nifdc.org.cn
Supported by:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

Abstract

Abstract:

The authorized generic drugs (AGs) are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug (usually refers to an innovator drug). Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the brand name product. In China, for those published comparator products of generic drug products, the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs. In the present paper, we systemically elaborated the definition, classification and relevant background of the AGs, as well as their differences to the generic drugs. At the same time, by taking drug products, which are adopted in the Chinese comparator product directories for generic medicinal products (first batch) and sourced from USA orange book, as examples, we introduced the searching process of the AGs with the integration of FDA listing of AGs, the USA orange book and the USA national drug code directory. It can facilitate the domestic and foreign pharmaceutical enterprises to search, identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.

Key words: Authorized generic drugs, New drug application, National drug code, Comparator product, Re-evaluation of generic medicinal product, Orange book

CLC Number:

R951

Supporting:

Dongsheng Yang, Lingyun Ma, Jianzhao Niu, Mingdi Xu. Brief introduction for application of USA authorized generic drugs[J]. Journal of Chinese Pharmaceutical Sciences, 2019, 28(6): 439-445.

References

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[2] China Food and Drug Administration. Related Matters concerned to the Published Comparator Product [EB/OL]. [2017-08-18]. http://samr.cfda.gov.cn/WS01/CL1751/ 176236.html.

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[7] US FDA. Referencing Approved Drug Products in ANDA Submissions, DRAFT GUIDANCE, January 2017 [EB/OL]. [2017-01]. https://www.fda.gov/downloads/drugs/guidance complianceregulatoryinformation/guidances/ucm536962.pdf.

[8] US FDA. FDA Listing of Authorized Generics [EB/OL]. [2019-03-28]. https://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ucm126391.htm.

[9] US FDA. Generic Drugs [EB/OL]. [2018-06-05]. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/default.htm.

[10] US FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book, 38th Edition) [EB/OL]. [2018-01-01] https://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/UCM071436.pdf.

[11] China Food and Drug Administration. Guidelines for selection and determination of Comparator Product for Immediate Release Solid Oral Dosage Forms (No. 61 in 2016) [EB/OL]. [2016-03-18]. http://www.sda.gov.cn/WS01/CL1751/147583.html.

[12] Center for Drug Evaluation of National Medical Products Administration. Publicity on the release of 21 st batch of Chinese Comparator Product directories for generic medicinal product [EB/OL]. [2019-03-28]. http://www.cde.org.cn/news.do?method=viewInfo Common&id=314837.

[13] China Food and Drug Administration.CFDA’s announcement on the release of first batch of Chinese Comparator Product directories for generic medicinal product (No. 45 in 2017) [EB/OL]. [2017-03-17]. http://www.sda.gov.cn/WS01/CL1757/170862.html.

[14] US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations [EB/OL]. [2019-03]. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.

[15] Yang, D.S.; Ma, L.Y.; Niu, J.Z.; Xu, M.D. Brief introduction for application of the USA national drug code. J. Chin. Pharm. Sci. 2019, 28, 203-208.

Brief introduction for application of USA authorized generic drugs

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