<strong>Background:</strong> <span><span style="font-family:Verdana;">Omega-3 polyunsaturated fatty acids (PUFAs) have some protective benefits for patients with coronary artery and c...<strong>Background:</strong> <span><span style="font-family:Verdana;">Omega-3 polyunsaturated fatty acids (PUFAs) have some protective benefits for patients with coronary artery and cerebrovascular diseases. Eicosapentaenoic acid (EPA) drugs are prescribed as branded (B: EPADEL</span><sup><span style="font-family:Verdana;"><span style="color:#4F4F4F;font-family:-apple-system, " font-size:14px;white-space:normal;background-color:#ffffff;"="">?</span></span></sup><span style="font-family:Verdana;">) or generic products but no data exist concerning the differences in treatment outcomes between these products. </span><b><span style="font-family:Verdana;">Methods and Results: </span></b><span style="font-family:Verdana;">We investigated the differences in the serum levels of EPA, docosahexaenoic acid (DHA) and arachidonic acid (AA), and the EPA/AA ratios through blood sampling six months after daily administration of 1800 mg of EPADEL</span><sup><span style="font-family:Verdana;"><span style="color:#4F4F4F;font-family:-apple-system, " font-size:14px;white-space:normal;background-color:#ffffff;"="">?</span></span></sup><span style="font-family:Verdana;"> and a generic EPA drug was initiated for 96 patients with cardiovascular diseases. All patients received these PUFA treatments while continuing with baseline therapy. After 6 months of administration, EPADEL</span><sup><span style="font-family:Verdana;"><span style="color:#4F4F4F;font-family:-apple-system, " font-size:14px;white-space:normal;background-color:#ffffff;"="">?</span></span></sup><span style="font-family:Verdana;"> produced better results than the generic (G) product (EPA;baseline: 59.4 ± 25.5 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, B: 215.5 ± 58.8 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, G: 199.7 ± 63.8 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, B vs G, p < 0.0005;AA;baseline: 197.4 ± 44.6 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, B: 158.3 ± 36.3 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, G: 163.6 ± 38.9 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, B vs G, p < 0.02, as mean ± SD). </span><b><span style="font-family:Verdana;">Conclusions</span></b></span><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> There were clear differences between EPA branded and the generic products. Further study is required to determine whether the benefits from the branded product justify the higher price compared to the generic drug cost.</span>展开更多
It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Ad...It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product.To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this paper.At the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.展开更多
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...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.展开更多
The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significane...The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.展开更多
The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential...The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.展开更多
文摘<strong>Background:</strong> <span><span style="font-family:Verdana;">Omega-3 polyunsaturated fatty acids (PUFAs) have some protective benefits for patients with coronary artery and cerebrovascular diseases. Eicosapentaenoic acid (EPA) drugs are prescribed as branded (B: EPADEL</span><sup><span style="font-family:Verdana;"><span style="color:#4F4F4F;font-family:-apple-system, " font-size:14px;white-space:normal;background-color:#ffffff;"="">?</span></span></sup><span style="font-family:Verdana;">) or generic products but no data exist concerning the differences in treatment outcomes between these products. </span><b><span style="font-family:Verdana;">Methods and Results: </span></b><span style="font-family:Verdana;">We investigated the differences in the serum levels of EPA, docosahexaenoic acid (DHA) and arachidonic acid (AA), and the EPA/AA ratios through blood sampling six months after daily administration of 1800 mg of EPADEL</span><sup><span style="font-family:Verdana;"><span style="color:#4F4F4F;font-family:-apple-system, " font-size:14px;white-space:normal;background-color:#ffffff;"="">?</span></span></sup><span style="font-family:Verdana;"> and a generic EPA drug was initiated for 96 patients with cardiovascular diseases. All patients received these PUFA treatments while continuing with baseline therapy. After 6 months of administration, EPADEL</span><sup><span style="font-family:Verdana;"><span style="color:#4F4F4F;font-family:-apple-system, " font-size:14px;white-space:normal;background-color:#ffffff;"="">?</span></span></sup><span style="font-family:Verdana;"> produced better results than the generic (G) product (EPA;baseline: 59.4 ± 25.5 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, B: 215.5 ± 58.8 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, G: 199.7 ± 63.8 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, B vs G, p < 0.0005;AA;baseline: 197.4 ± 44.6 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, B: 158.3 ± 36.3 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, G: 163.6 ± 38.9 </span><span style="font-family:Verdana;">μ</span><span style="font-family:Verdana;">g, B vs G, p < 0.02, as mean ± SD). </span><b><span style="font-family:Verdana;">Conclusions</span></b></span><b><span style="font-family:Verdana;">:</span></b><span style="font-family:Verdana;"> There were clear differences between EPA branded and the generic products. Further study is required to determine whether the benefits from the branded product justify the higher price compared to the generic drug cost.</span>
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product.To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this paper.At the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘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.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.
基金Carry out quality evaluation research of generic medicinal product control based on domestic product,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing,China。
文摘The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.
