Objective:Generic drugs provide an opportunity for savings in drug expenditure since they are available at a lower cost and do not affect patients’health.A better understanding of pharmacists’knowledge,attitudes,and...Objective:Generic drugs provide an opportunity for savings in drug expenditure since they are available at a lower cost and do not affect patients’health.A better understanding of pharmacists’knowledge,attitudes,and perception can promote the quality use of generic drugs.The objective of this study was to investigate the knowledge,attitudes,and perception of pharmacists from tertiary hospitals in China regarding generic drugs.Methods:A cross-sectional survey using a postal questionnaire was conducted,which was sent to 200 hospital pharmacists randomly selected from tertiary hospitals in Hubei Province.A total of 125 questionnaires out of 200 were received.Of the respondents,80 were female and 45 were male.Results:The majority of respondents(87.2%)could clearly distinguish between original and generic drugs.Pharmacists agreed that generic drugs were less effective(52.8%)and produced more side effects(52%).Forty-nine respondents thought that generic drug products were not adequately tested.Approximately 78% and 60% of the pharmacists indicated that generic substitution was not feasible for drugs with narrow therapeutic windows and drugs for critical diseases,respectively.Most of them supported the recommendation of generic drugs based on professional judgment.Conclusion:Our study showed that a considerable portion of Chinese hospital pharmacists hold negative perceptions of generic drugs.Interventions to improve pharmacists'knowledge of generic drugs are needed.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
Perceptions of Chinese pharmacists towards generic drugs were evaluated by a cross-sectional study from Aug.2018 to Dec.2018.Online survey tool Sojump was adopted to release the questionnaires using convenience sampli...Perceptions of Chinese pharmacists towards generic drugs were evaluated by a cross-sectional study from Aug.2018 to Dec.2018.Online survey tool Sojump was adopted to release the questionnaires using convenience sampling.A total of 577 questionnaires by pharmacists were analyzed.A meaningful proportion of pharmacists expressed negative perceptions of generic drugs,such as perceiving generics as less effective,less safe and more likely to cause side effects compared to their branded equivalents.Educational campaigns that focus on misperceptions of generic drugs may be necessary.展开更多
Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus...Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus on developing the generic drug products because huge amount of investment is required for innovation and to develop reference product. The generic medicine has to be bioequivalent to the innovator drug and ensure the same biological effect with proper safety and efficacy. Nowadays, the pharmaceutical industries focus on the development of generic product as this does not require that much time and cost compared to the innovator company. But development of generic product is also difficult as it contains the same therapeutic efficacy as innovator. The development approach is based on the target market, i.e. US market, EU market. If a manufacturer targets the US market, then all excipients should be USP grade, analysis should be conducted by USP method or in-house method and stability studies as well. Prior and during the development of generic drug product API selection, dosage form selection, reference product selection and characterization, formulation development, analytical method development, tech transfer or submission batch are prime concern. Then again, bioequivalence study, drug registration procedure and commercialization of the generic product considering regulatory guidance of respective regulatory agencies and the approaches taken by the regulatory agencies for the development of registration of generic medicines are also crucial as well for the development of generic drug product. The aim of this study was to review the entire stage of a generic drug development by a generic pharmaceutical company.展开更多
Objective To study the significance of authorized generic drugs due to the successive relevant documents issued by China’s government in recent years,which clearly stipulated that China should establish a drug patent...Objective To study the significance of authorized generic drugs due to the successive relevant documents issued by China’s government in recent years,which clearly stipulated that China should establish a drug patent linkage system.Methods The authorized generic drugs play an important role in keeping the balance between brandname drugs and generic drugs in the US.Therefore,this system was investigated,focusing on its difference from independent generics,marketing procedures,application in patent litigation and legitimacy analysis through case evidence.This analogy analysis could provide a reference for the research of authorized generic drug systems in China.Results and Conclusion As an important factor affecting the balance between brand-name drugs and generic drugs,authorized generic drugs should be comprehensively analyzed and discussed,and a suitable system for China’s national conditions should be established by referring to the experiences of the US.展开更多
Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives fo...Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.展开更多
Objective To find out several patented technologies of antihypertensive drugs with the most market value through analysis,and provide a reference for the research and development of enterprises.Methods The most valuab...Objective To find out several patented technologies of antihypertensive drugs with the most market value through analysis,and provide a reference for the research and development of enterprises.Methods The most valuable patented technologies of antihypertensive drugs from 2009 to 2019 were analyzed to explore the patent layout and technical characteristics of the main patent applicants,and then the key directions of their research and development were gotten.Results and Conclusion Based on the method of patent analysis,five patents with the most market value are extracted to provide important technical support and market value reference for the research and development of generic drugs or new drugs.展开更多
Background:Generic drugs are bioequivalent to their brand-name counterparts;however,concerns still exist regarding the effectiveness and safety of generic drugs because of small sample sizes and short follow-up time i...Background:Generic drugs are bioequivalent to their brand-name counterparts;however,concerns still exist regarding the effectiveness and safety of generic drugs because of small sample sizes and short follow-up time in most studies.The purpose of this study was to evaluate the long-term antihypertensive efficacy,cost-effectiveness and cardiovascular outcomes of generic drugs compared with brand-name drugs.Methods:In a multicenter,community-based study including 7955 hypertensive patients who were prospectively followed up for an average of 2.5 years,we used the propensity-score-matching method to match the patients using brand-name drugs to those using generic drugs in a ratio of 1:2,2176 patients using brand-name drugs and 4352 patients using generic drugs.Results:There were no significant differences between generic drugs and brand-name drugs in blood pressure(BP)-lowering efficacy,BP control rate,and cardiovascular outcomes including coronary heart disease and stroke.The adjusted mean(95%confidence interval[CI])of systolic BP(SBP)-lowering was-7.9 mmHg(95%CI,-9.9 to-5.9)in the brand-name drug group and-7.1 mmHg(95%CI,-9.1 to-5.1)in the generic drug group after adjusting for age,sex,body mass index,number of antihypertensive drugs and traditionally cardiovascular risk factors.Among patients aged<60 years,brand-name drugs had a higher BP control rate(47%vs.41%;P=0.02)and a greater effect in lowering SBP compared with generic drugs,with the between-group difference of 1.5 mmHg(95%CI,0.2-2.8;P=0.03).BP control rate was higher in male patients using brand-name drugs compared with those using generic drugs(46%vs.40%;P=0.01).Generic drugs treatment yielded an average annual incremental cost-effectiveness ratio of$315.4 per patient per mmHg decrease in SBP compared with brand-name drugs treatment.Conclusions:Our data suggested that generic drugs are suitable and cost-effective in improving hypertension management and facilitating public health benefits,especially in low-and middle-income areas.展开更多
Objective To provide reference for the development strategy of China’s enterprises under the current policy background of generic drug consistency evaluation and volume procurement.Methods China’s current policies o...Objective To provide reference for the development strategy of China’s enterprises under the current policy background of generic drug consistency evaluation and volume procurement.Methods China’s current policies on generic drugs and market environment were analyzed and the development paths of international top pharmaceutical enterprises were studied as well.Results and Conclusion There are four transformation and upgrading paths for China’s pharmaceutical enterprises.First,they should invest more in innovation to realize the globalization of new drugs.Second,overseas patented new drugs should be introduced actively.Third,they must focus on the research and development of high-end generic drugs.Lastly,the transformation from active pharmaceutical ingredients into pharmaceutic preparation should be carried out quickly.Under the background of volume procurement,the pharmaceutical market pattern will be completely changed.The research and development capability and patented drugs will become the core competitive advantages of enterprises.展开更多
Background:Cyclosporine A and tacrolimus(TAC)are often used as a second-line treatment for children with refractory nephrotic syndrome(NS).This study was undertaken to investigate the efficacy and safety of Tacrobell&...Background:Cyclosporine A and tacrolimus(TAC)are often used as a second-line treatment for children with refractory nephrotic syndrome(NS).This study was undertaken to investigate the efficacy and safety of Tacrobell®,a locally produced generic form of TAC.Methods:This study was a one-year prospective,open-label,single-arm,multicenter trial.Fourty-four children with steroid-dependent NS(SDNS)and 33 children with steroid-resistant NS(SRNS)were enrolled.The primary endpoints were defined as the remission rates,whereas the secondary endpoints were recognized as the duration of remission and adverse effects of TAC.Results:After one-year treatment,34(77.3%)of the 44 patients with SDNS were in complete remission,and 6(13.6%)were in partial remission.Nineteen(43.2%)patients did not relapse during the study;for those who did relapse,the mean duration of remission was 4.6±2.9 months.The number of relapse episodes during the study period(0.90 per patient-year)was significantly lower than that in the preceding year(2.8 per patientyear).After treatment for 3 and 6 months,12(36.4%)of the 33 patients with SRNS were in remission,and after treatment for 12 months,the number of patients had increased to 13(39.4%).The mean time to achieve remission was 4.0±3.2 months.After remission(duration,3.7±2.7 months),12(54.5%)of 22 patients relapsed.The fasting blood glucose and blood pressure levels during the therapy were similar to those at the time of study entry.Conclusions:Treatment with Tacrobell®was effective and safe for children with refractory NS.The efficacy of this generic form of TAC was better than that of the original TAC formula.展开更多
The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“swi...The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“switchability”,bioequivalence for complicated dosage forms,patent extension,generic drug safety,generic substitution and low-cost generics.The backlog in generic review,generic drug user fees,and“quality by design”for generic drugs is also discussed.The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.展开更多
In the present study, we aimed to compare the efficacy and adherence of Runzhong;(generic drug, Chiatai Tianqing,Nanjing) and Baraclude;(branded drug, Bristol-Myers Squibb) in patients with chronic hepatitis B. We col...In the present study, we aimed to compare the efficacy and adherence of Runzhong;(generic drug, Chiatai Tianqing,Nanjing) and Baraclude;(branded drug, Bristol-Myers Squibb) in patients with chronic hepatitis B. We collected patient data from three hospitals within 48 weeks and compared the two groups by using the propensity-score matching method. A total of 4889 patients were enrolled in this study;503 initiated a brand-name drug, and 4386 received a generic drug. There was no significant difference in the rates of CVR(complete virologic response) and VB(virologic breakthrough) between the Runzhong;group and Baraclude;group at 24 and 48 weeks. Similar results for HBeAg loss, medication possession ratio(MPR), and biological response were obtained. Age, gender(HR 0.909(0.842–0.981)), normal baseline ALT rate(HR 0.789(0.731–0.851)), HBeAg-positive rate, and baseline undetectable HBV DNA rate(HR 0.306(0.234–0.399)) were independent factors for achieving CVR.展开更多
The aim of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of ago...The aim of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects. This was performed in a single-dose, randomized-sequence, open-label, four-way crossover study with a one-day washout period between doses. Healthy Chinese males were randomly assigned to receive 25 mg of either the test or reference formulation. The formulations were considered bioequivalent if 90% confidence intervals (CIs) for the log-transformed ratios and ratio of geometric means (GMR) of AUC and C m of agomelatine were within the predetermined bioequivalence range based on RSABE method. Results showed that both of the 90% CIs for the log-transformed ratios of AUC and C-max of 7-desmethyl-agomelatine and 3-hydroxyagomelatine were within the predetermined bioequivalence range. The 90% CIs for natural log transformed ratios of C-max, AUC(0-t), and AUC(0-infinity) of agomelatine (104.42-139.86, 101.33-123.83 and 97.90-117.94) were within the RSABE acceptance limits, and 3-hydroxy-agomelatine (105.55-123.03, 101.95-109.10 and 101.72-108.70) and 7-desmethyl-agomelatine (104.50-125.23, 102.36-111.50 and 101.62-110.64) were within the FDA bioequivalence definition intervals (0.80-1.25 for AUC and 0.75-1.33 for C-max). The RSABE approach was successful in evaluating the bioequivalence of these two formulations. (C) 2016 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V.展开更多
In the present study, we aimed to compare the pharmacokinetics and pharmacodynamics between Glucophage~? and a generic metformin formulation in a diabetic rat model in order to assess the bioequivalence of the generic...In the present study, we aimed to compare the pharmacokinetics and pharmacodynamics between Glucophage~? and a generic metformin formulation in a diabetic rat model in order to assess the bioequivalence of the generic formulation. Adult male Zucker diabetes fatty rats received Glucophage~? or the generic metformin through gastric gavage at a dose of 180 mg/kg(n = 6 per condition). Both pharmacokinetic parameters(AUC0–t, AUC0–∞, Cmax) of metformin and plasma glucose levels were compared between the two groups. For pharmacodynamics, rats received Glucophage~? or the generic metformin at doses of 180 and 300 mg·kg–1·d–1 for 6 weeks. The measurements included body weight, fasting plasma glucose, glycosylated serum protein(GSP) and serum insulin. Data were analyzed with SPSS 22.0 and Prism 7. The level of statistical significance was set at P<0.05. In single dosing experiments, pharmacokinetic parameters(t1/2, AUC0–t and Cmax) did not differ between Glucophage~? and the generic metformin(P>0.05). However, plasma glucose was significantly higher in the generic metformin group at 2 h(P = 0.03) and 4 h(P = 0.04) after drug treatment. In repeated dosing experiments, fasting glucose, HOMA-IR and body weight in rats receiving high-dose Glucophage~? were significantly lower at the end of the 6-week treatment period than those in rats receiving high-dose generic metformin(P<0.05 for all). GSP and serum insulin did not differ significantly between the two groups. In rats receiving low-dose metformin, fasting glucose was lower in the Glucophage~? group. HOMA-IR and body weight did not differ between the two groups. Moreover, blood lipids did not differ significantly between the two groups. The generic metformin used in the current study did not differ significantly in pharmacokinetic characteristics with Glucophage~?. However, Glucophage~? was superior in terms of glucose control, body weight loss and insulin sensitivity in repeated administration.展开更多
基金supported by the National Natural Science Foundation of China(No.71373089).
文摘Objective:Generic drugs provide an opportunity for savings in drug expenditure since they are available at a lower cost and do not affect patients’health.A better understanding of pharmacists’knowledge,attitudes,and perception can promote the quality use of generic drugs.The objective of this study was to investigate the knowledge,attitudes,and perception of pharmacists from tertiary hospitals in China regarding generic drugs.Methods:A cross-sectional survey using a postal questionnaire was conducted,which was sent to 200 hospital pharmacists randomly selected from tertiary hospitals in Hubei Province.A total of 125 questionnaires out of 200 were received.Of the respondents,80 were female and 45 were male.Results:The majority of respondents(87.2%)could clearly distinguish between original and generic drugs.Pharmacists agreed that generic drugs were less effective(52.8%)and produced more side effects(52%).Forty-nine respondents thought that generic drug products were not adequately tested.Approximately 78% and 60% of the pharmacists indicated that generic substitution was not feasible for drugs with narrow therapeutic windows and drugs for critical diseases,respectively.Most of them supported the recommendation of generic drugs based on professional judgment.Conclusion:Our study showed that a considerable portion of Chinese hospital pharmacists hold negative perceptions of generic drugs.Interventions to improve pharmacists'knowledge of generic drugs are needed.
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.
文摘Perceptions of Chinese pharmacists towards generic drugs were evaluated by a cross-sectional study from Aug.2018 to Dec.2018.Online survey tool Sojump was adopted to release the questionnaires using convenience sampling.A total of 577 questionnaires by pharmacists were analyzed.A meaningful proportion of pharmacists expressed negative perceptions of generic drugs,such as perceiving generics as less effective,less safe and more likely to cause side effects compared to their branded equivalents.Educational campaigns that focus on misperceptions of generic drugs may be necessary.
文摘Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus on developing the generic drug products because huge amount of investment is required for innovation and to develop reference product. The generic medicine has to be bioequivalent to the innovator drug and ensure the same biological effect with proper safety and efficacy. Nowadays, the pharmaceutical industries focus on the development of generic product as this does not require that much time and cost compared to the innovator company. But development of generic product is also difficult as it contains the same therapeutic efficacy as innovator. The development approach is based on the target market, i.e. US market, EU market. If a manufacturer targets the US market, then all excipients should be USP grade, analysis should be conducted by USP method or in-house method and stability studies as well. Prior and during the development of generic drug product API selection, dosage form selection, reference product selection and characterization, formulation development, analytical method development, tech transfer or submission batch are prime concern. Then again, bioequivalence study, drug registration procedure and commercialization of the generic product considering regulatory guidance of respective regulatory agencies and the approaches taken by the regulatory agencies for the development of registration of generic medicines are also crucial as well for the development of generic drug product. The aim of this study was to review the entire stage of a generic drug development by a generic pharmaceutical company.
文摘Objective To study the significance of authorized generic drugs due to the successive relevant documents issued by China’s government in recent years,which clearly stipulated that China should establish a drug patent linkage system.Methods The authorized generic drugs play an important role in keeping the balance between brandname drugs and generic drugs in the US.Therefore,this system was investigated,focusing on its difference from independent generics,marketing procedures,application in patent litigation and legitimacy analysis through case evidence.This analogy analysis could provide a reference for the research of authorized generic drug systems in China.Results and Conclusion As an important factor affecting the balance between brand-name drugs and generic drugs,authorized generic drugs should be comprehensively analyzed and discussed,and a suitable system for China’s national conditions should be established by referring to the experiences of the US.
文摘Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.
文摘Objective To find out several patented technologies of antihypertensive drugs with the most market value through analysis,and provide a reference for the research and development of enterprises.Methods The most valuable patented technologies of antihypertensive drugs from 2009 to 2019 were analyzed to explore the patent layout and technical characteristics of the main patent applicants,and then the key directions of their research and development were gotten.Results and Conclusion Based on the method of patent analysis,five patents with the most market value are extracted to provide important technical support and market value reference for the research and development of generic drugs or new drugs.
基金China National Center for Biotechnology Development fund(Nos.2018YFC1312400,2018YFC1312405)National Science and Technology Pillar Program during the Twelfth Five-year Plan Period(No.2011BAI11B04)Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences(No.2016-I2M-1-006)。
文摘Background:Generic drugs are bioequivalent to their brand-name counterparts;however,concerns still exist regarding the effectiveness and safety of generic drugs because of small sample sizes and short follow-up time in most studies.The purpose of this study was to evaluate the long-term antihypertensive efficacy,cost-effectiveness and cardiovascular outcomes of generic drugs compared with brand-name drugs.Methods:In a multicenter,community-based study including 7955 hypertensive patients who were prospectively followed up for an average of 2.5 years,we used the propensity-score-matching method to match the patients using brand-name drugs to those using generic drugs in a ratio of 1:2,2176 patients using brand-name drugs and 4352 patients using generic drugs.Results:There were no significant differences between generic drugs and brand-name drugs in blood pressure(BP)-lowering efficacy,BP control rate,and cardiovascular outcomes including coronary heart disease and stroke.The adjusted mean(95%confidence interval[CI])of systolic BP(SBP)-lowering was-7.9 mmHg(95%CI,-9.9 to-5.9)in the brand-name drug group and-7.1 mmHg(95%CI,-9.1 to-5.1)in the generic drug group after adjusting for age,sex,body mass index,number of antihypertensive drugs and traditionally cardiovascular risk factors.Among patients aged<60 years,brand-name drugs had a higher BP control rate(47%vs.41%;P=0.02)and a greater effect in lowering SBP compared with generic drugs,with the between-group difference of 1.5 mmHg(95%CI,0.2-2.8;P=0.03).BP control rate was higher in male patients using brand-name drugs compared with those using generic drugs(46%vs.40%;P=0.01).Generic drugs treatment yielded an average annual incremental cost-effectiveness ratio of$315.4 per patient per mmHg decrease in SBP compared with brand-name drugs treatment.Conclusions:Our data suggested that generic drugs are suitable and cost-effective in improving hypertension management and facilitating public health benefits,especially in low-and middle-income areas.
文摘Objective To provide reference for the development strategy of China’s enterprises under the current policy background of generic drug consistency evaluation and volume procurement.Methods China’s current policies on generic drugs and market environment were analyzed and the development paths of international top pharmaceutical enterprises were studied as well.Results and Conclusion There are four transformation and upgrading paths for China’s pharmaceutical enterprises.First,they should invest more in innovation to realize the globalization of new drugs.Second,overseas patented new drugs should be introduced actively.Third,they must focus on the research and development of high-end generic drugs.Lastly,the transformation from active pharmaceutical ingredients into pharmaceutic preparation should be carried out quickly.Under the background of volume procurement,the pharmaceutical market pattern will be completely changed.The research and development capability and patented drugs will become the core competitive advantages of enterprises.
基金supported by a grant from the Korean Health Technology R&D Project,Ministry of Health&Welfare,Republic of Korea(HI12C0014)Basic Science Research Program through the National Research Foundation of Korea(NRF)funded by the Ministry of Education(NRF-2012R1A1A2006858)+1 种基金Chong Kun Dang Pharmaceutical Corp.,Seoul,Koreaapproved by the Institutional Review Board of Seoul National University Hospital(No.0911-027-300).
文摘Background:Cyclosporine A and tacrolimus(TAC)are often used as a second-line treatment for children with refractory nephrotic syndrome(NS).This study was undertaken to investigate the efficacy and safety of Tacrobell®,a locally produced generic form of TAC.Methods:This study was a one-year prospective,open-label,single-arm,multicenter trial.Fourty-four children with steroid-dependent NS(SDNS)and 33 children with steroid-resistant NS(SRNS)were enrolled.The primary endpoints were defined as the remission rates,whereas the secondary endpoints were recognized as the duration of remission and adverse effects of TAC.Results:After one-year treatment,34(77.3%)of the 44 patients with SDNS were in complete remission,and 6(13.6%)were in partial remission.Nineteen(43.2%)patients did not relapse during the study;for those who did relapse,the mean duration of remission was 4.6±2.9 months.The number of relapse episodes during the study period(0.90 per patient-year)was significantly lower than that in the preceding year(2.8 per patientyear).After treatment for 3 and 6 months,12(36.4%)of the 33 patients with SRNS were in remission,and after treatment for 12 months,the number of patients had increased to 13(39.4%).The mean time to achieve remission was 4.0±3.2 months.After remission(duration,3.7±2.7 months),12(54.5%)of 22 patients relapsed.The fasting blood glucose and blood pressure levels during the therapy were similar to those at the time of study entry.Conclusions:Treatment with Tacrobell®was effective and safe for children with refractory NS.The efficacy of this generic form of TAC was better than that of the original TAC formula.
文摘The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“switchability”,bioequivalence for complicated dosage forms,patent extension,generic drug safety,generic substitution and low-cost generics.The backlog in generic review,generic drug user fees,and“quality by design”for generic drugs is also discussed.The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.
基金Beijing Pharmacological Society and Science Foundation of Sichuan Education Department (Grant No. 18ZA0186)。
文摘In the present study, we aimed to compare the efficacy and adherence of Runzhong;(generic drug, Chiatai Tianqing,Nanjing) and Baraclude;(branded drug, Bristol-Myers Squibb) in patients with chronic hepatitis B. We collected patient data from three hospitals within 48 weeks and compared the two groups by using the propensity-score matching method. A total of 4889 patients were enrolled in this study;503 initiated a brand-name drug, and 4386 received a generic drug. There was no significant difference in the rates of CVR(complete virologic response) and VB(virologic breakthrough) between the Runzhong;group and Baraclude;group at 24 and 48 weeks. Similar results for HBeAg loss, medication possession ratio(MPR), and biological response were obtained. Age, gender(HR 0.909(0.842–0.981)), normal baseline ALT rate(HR 0.789(0.731–0.851)), HBeAg-positive rate, and baseline undetectable HBV DNA rate(HR 0.306(0.234–0.399)) were independent factors for achieving CVR.
基金supported by the National Natural Science Foundation of China(No.81102499)Hunan Science and Technology Project(No.2011SK3261)+1 种基金the Fundamental Research Funds for the Central Universities of Central South University(No.2014zzts313)the support from Chongqing Fu An Pharmaceutical Group Qingyutang Pharmaceutical Co.,Ltd
文摘The aim of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects. This was performed in a single-dose, randomized-sequence, open-label, four-way crossover study with a one-day washout period between doses. Healthy Chinese males were randomly assigned to receive 25 mg of either the test or reference formulation. The formulations were considered bioequivalent if 90% confidence intervals (CIs) for the log-transformed ratios and ratio of geometric means (GMR) of AUC and C m of agomelatine were within the predetermined bioequivalence range based on RSABE method. Results showed that both of the 90% CIs for the log-transformed ratios of AUC and C-max of 7-desmethyl-agomelatine and 3-hydroxyagomelatine were within the predetermined bioequivalence range. The 90% CIs for natural log transformed ratios of C-max, AUC(0-t), and AUC(0-infinity) of agomelatine (104.42-139.86, 101.33-123.83 and 97.90-117.94) were within the RSABE acceptance limits, and 3-hydroxy-agomelatine (105.55-123.03, 101.95-109.10 and 101.72-108.70) and 7-desmethyl-agomelatine (104.50-125.23, 102.36-111.50 and 101.62-110.64) were within the FDA bioequivalence definition intervals (0.80-1.25 for AUC and 0.75-1.33 for C-max). The RSABE approach was successful in evaluating the bioequivalence of these two formulations. (C) 2016 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V.
基金The National Key Development Plan for Precision Medicine Research(Grant No.2017YFC0910004)Jinan Science Project(Grant No.201602171)
文摘In the present study, we aimed to compare the pharmacokinetics and pharmacodynamics between Glucophage~? and a generic metformin formulation in a diabetic rat model in order to assess the bioequivalence of the generic formulation. Adult male Zucker diabetes fatty rats received Glucophage~? or the generic metformin through gastric gavage at a dose of 180 mg/kg(n = 6 per condition). Both pharmacokinetic parameters(AUC0–t, AUC0–∞, Cmax) of metformin and plasma glucose levels were compared between the two groups. For pharmacodynamics, rats received Glucophage~? or the generic metformin at doses of 180 and 300 mg·kg–1·d–1 for 6 weeks. The measurements included body weight, fasting plasma glucose, glycosylated serum protein(GSP) and serum insulin. Data were analyzed with SPSS 22.0 and Prism 7. The level of statistical significance was set at P<0.05. In single dosing experiments, pharmacokinetic parameters(t1/2, AUC0–t and Cmax) did not differ between Glucophage~? and the generic metformin(P>0.05). However, plasma glucose was significantly higher in the generic metformin group at 2 h(P = 0.03) and 4 h(P = 0.04) after drug treatment. In repeated dosing experiments, fasting glucose, HOMA-IR and body weight in rats receiving high-dose Glucophage~? were significantly lower at the end of the 6-week treatment period than those in rats receiving high-dose generic metformin(P<0.05 for all). GSP and serum insulin did not differ significantly between the two groups. In rats receiving low-dose metformin, fasting glucose was lower in the Glucophage~? group. HOMA-IR and body weight did not differ between the two groups. Moreover, blood lipids did not differ significantly between the two groups. The generic metformin used in the current study did not differ significantly in pharmacokinetic characteristics with Glucophage~?. However, Glucophage~? was superior in terms of glucose control, body weight loss and insulin sensitivity in repeated administration.
