Brand-name Products Research Articles

Challenges in gaining supply chain competitiveness: Supplier response strategies and determinants

This study aimed to explore suppliers' response strategies to their biggest challenge when they are dealing with brand name manufacturers and uncover the driving forces underlying such strategies. Based on face-to-face interviews with 1075 electronic component suppliers in China, we identified suppliers' biggest challenges and classified their response strategies into these categories: strategic marketing, operations and human resources, and economic. Drawing from the resource-based view of the firm, interorganizational relationship theory, and transaction cost economics, coupled with the results from our in-depth interviews, we argue that the type of supplier response strategies depends on the type of challenge faced as well as various transaction and customer characteristics. Our empirical study demonstrated that these driving forces significantly affect suppliers' strategic responses in different ways. Our study contributes to the literature on brand management in the B2B setting, by investigating how suppliers effectively tackle their biggest challenges from brand name manufacturers to gain competitive advantages.

The Influence of Product Features, Brand Name, Price, and Social Influence towards Purchase Intention of iPhone in Indonesia

The Influence of Product Features, Brand Name, Price, and Social Influence towards Purchase Intention of iPhone in Indonesia

The adoption of generic immunosuppressant medications in kidney, liver, and heart transplantation among recipients in Colorado or nationally with Medicare part D.

The transplant community is divided regarding whether substitution with generic immunosuppressants is appropriate for organ transplant recipients. We estimated the rate of uptake over time of generic immunosuppressants using US Medicare Part D Prescription Drug Event (PDE) and Colorado pharmacy claims (including both Part D and non-Part D) data from 2008 to 2013. Data from 26070 kidney, 15548 liver, and 6685 heart recipients from Part D, and 1138 kidney and 389 liver recipients from Colorado were analyzed. The proportions of patients with PDEs or claims for generic and brand-name tacrolimus or mycophenolate mofetil were calculated over time by transplanted organ and drug. Among Part D kidney, liver, and heart beneficiaries, the proportion dispensed generic tacrolimus reached 50%-56% at 1year after first generic approval and 78%-81% by December 2013. The proportion dispensed generic mycophenolate mofetil reached 70%-73% at 1year after generic market entry and 88%-90% by December 2013. There was wide interstate variability in generic uptake, with faster uptake in Colorado compared with most other states. Overall, generic substitution for tacrolimus and mycophenolate mofetil for organ transplant recipients increased rapidly following first availability, and utilization of generic immunosuppressants exceeded that of brand-name products within a year of market entry.

GLOBAL MANUFACTURING COLLABORATION: A CASE STUDY OF TAIWAN’s HON HAI PRECISION INDUSTRY COMPANY AND JAPAN’S SHARP CORPORATION

In April 2016, Taiwan’s Hon Hai Precision Industry Co. invests Japan’s leading electronics makers Sharp Corp. The strategic alliance does not focus on the financial advantages. On the contrary it focuses on increasing sales, strengthening supply chains and increasing manufacturing capabilities and productivity. The final objective of the alliance is to strengthen Sharps’s global competitiveness. After three quarters since the alliance is effective, Sharp is expecting a yearly gain compared to the loss for the last two years. This research summarizes the characteristics of both companies from their individual stories. Then, the research states the success of the alliance, and tries to explain the reasons of Sharp’s failure. This research then shows the key factors of the successful operation in the alliance. This research reviews the history and financial statements of Sharp. Finally we reach to a conclusion. That is, if the company could figure out the major problem actually was the organizational management, not the low demand and price of LCDs or the poor financial structure, the sorrow could be avoided. Finally, this research pinpoints the challenges of new Sharp in sales management of brand-name products and in debt management.

Cost pass-through in the Swedish coffee market

Cost pass-through to retail prices shows how changes in marginal costs are allocated between producers and consumers, and it is, therefore, closely related to market structure and competition. This paper uses Swedish data on coffee products at the barcode level to evaluate pass-through from the cost of green coffee beans, the main marginal cost, to the retail price of roasted and ground coffee. First long-run cost pass-through is estimated for each product, and then regression is used to analyse how pass-through varies across market shares, retailer-owned brands and other product characteristics. A general result is that pass-through is roughly complete for products with large market shares, while those with small market shares have low pass-through rates. There is no evidence that retailer-owned brands have higher pass-through than brand-name products with similar market shares, which would be the case if retailer-owned brands avoided double marginalisation through vertical integration. Thus, although there is not perfect competition in the Swedish coffee market, a large part of it appears to be highly competitive.

Investigation of the efficacy of generic and brand-name salmeterol/fluticasone combination in the management of asthma: a randomized comparative trial.

Background: Asthma is the most chronic inflammatory disease of the airways worldwide. Combination therapy with inhaled fluticasone and salmeterol is a common practice for the long-term management of asthma. Seretide® and Fluticort plus® are two available generic and brand name products of salmeterol/fluticasone. This study aimed to compare the efficacy and safety of these two drugs. Materials and Methods: In this randomized comparative, clinical trial, 80 asthmatic patients were allocated to Fluticort plus® (n=40) or Seretide® (n=40) for a period of 4 weeks. Patients with mild asthma were instructed to inhale one puff each 12 hours and those with moderate asthma two puffs every 12 hours. Respiratory volumes (assessed using spirometry), quality of life (assessed using St. George’s Respiratory Questionnaire [SGRQ]) and control of asthmatic symptoms (assessed using asthma control test [ACT]) were evaluated at baseline and at the end of the study. Results: ACT score improved only in the Fluticort plus® group (p=0.012) while it was not significantly changed in the Seretide® group (p=0.178). In both treatment groups, FEV1, FEV1/FVC, and total as well as subscale SGRQ scores were significantly improved by the end of the study (p<0.05). Seretide® more efficiently improved respiratory volumes and SGRQ score in comparison with Fluticort plus® (p<0.05). Conclusion: Our comparative trial indicated that generic fluticasone/salmeterol product could improve respiratory volumes, quality of life but its efficacy is lower than the brand-name product. However, Fluticort plus® improved asthma control more efficiently compared with Seretide®. (www.actabiomedica.it)

Evaluation of an appraisal regarding the establishment of Drug Information Service Center in the medical institution

Background: India has an exploding drug market in generic and brand name products with variable cost. Many doctors tend to rely on pharmaceutical representatives for their prescribing information. Now it is agreed that the major objectives of DISC are to provide a rational basis for choosing and using drugs skilfully to relieve patient’s ailments. This is becoming more and more important as the practicing doctors is now confronted with so called “newer drugs” at such a great pace that even a full- time pharmacologist sometimes finds it difficult to keep abreast of their merits and demerits. The DISC provides the knowledge of number of drugs for practical application while prescribing. To provide healthcare professionals and patients with immediate access to accurate, concise and unbiased information on drug therapy problems.Methods: This is randomized study is to be conducted to determine the opinions of doctors, medical students, nurses, patients, other non-medical staff and general public as a patient representation from our institute campus regarding necessity of drug information. They are provided written feedback forms to be filled. The drug information service center (DISC) routinely responds to queries/inquiries regarding various drug related information. A structured eleven points questionnaire containing both open and close ended questions is prepared for opinion poll in feed-back form.Results: Large majority of the health and non-health professionals of opinion poll are in favour of reforms &amp;innovations. They also suggested their own suggestions regarding the refreshing the subjects.Conclusions: It is essential to create awareness of the services provided by the DISC among physician’s pharmacists, nurses and consumers so that they should come forward to utilize these services.

Exploring the knowledge and attitude of medical and pharmacy students about generic medicine in Lahore, Pakistan

Background The age of out-of-pocket health-care expenditures demands the practice of generic medicine. Our objective was to evaluate the knowledge and attitude about generic medicine among medical and pharmacy students of Lahore, Pakistan. Methods A cross-sectional study was performed among calculated sample size (via online Raosoft calculator) of 295 students including 185 pharmacy and 110 medical students from third, fourth, and final year of studies using convenient sampling approach. A pre-validated questionnaire was used to assess the knowledge of students regarding generic medicine. Data were analyzed using SPSS version 20. Results We found that a majority of both pharmacy and medical students were aware of the meaning of brand and generic medicine where 86 (29.7%) students believed that generic medicine is bioequivalent to brand name product and 108 (36.5%) students agreed that cost burden will be reduced with the use of generics. There were concerns about quality (P ≤ 0.05) and side effects (P ≤ 0.005) of generic medicine as compared to brands. Significant associations were found between the knowledge of medical and pharmacy students (P ≤ 0.005). Conclusion Educational interventions and policies regarding generic medicine practices are strongly needed to overcome the knowledge deficits among pharmacy and medical students.

Department vs discount retail store patronage: effects of self-image congruence

PurposeThis paper explores the antecedents and consequences of consumers’ need for self-image congruence on their retail patronage of department (high-end) and discount (low-end) stores to purchase name-brand products in two product categories, apparel and home décor. It also compared online to offline shopping and considered two mediator variables, frugality and materialism.Design/methodology/approachThe paper analyzed the hypothesized relationships using structural equation modeling (SEM) and MANOVA. Study 1 suggested the model using secondary data, and Study 2 measured and confirmed the relationships using scenario-based online survey data. An MANOVA test was used to compare the shopping behavior of consumers with high and low need for self-image congruence.FindingsA strong causal link was found between concern with appearance and need for self-image congruence, and a positive relationship between need for self-image congruence and high- and low-end retail store patronage offline and online. While the group with high (vs low) need for self-image congruence was more likely to patronize department stores, unexpectedly, both the high and low self-image congruence groups were equally likely to shop at discount stores.Practical implicationsThe findings suggest that marketing messages focusing on concern for appearance may succeed by tapping into consumers’ need for self-image congruence with brand product/retail store images. Results also showed that consumers with high self-image congruence often patronize discount retail stores, suggesting marketing opportunities for low-end retailers.Originality/valueBecause consumers with high need for self-image congruence patronize both department and discount stores, it is suggested that self-image congruity may be multi-dimensional. The current study is also the first to examine structural relationships to test patronage behavior between department and discount stores offline and online.

Conspicuous consumption in emerging market: The case of Chinese migrant workers

The urbanization in transitional economies of emerging markets creates a unique consumer segment, migrant workers, and meanwhile brings opportunities and challenges to multinational marketers of name-brand products. This study investigates the relationship between social identity and conspicuous consumption in such a largely overlooked and untapped market in China. Our findings indicate that migrant workers' conspicuous consumption, as indicated by their purchase of name-brand products, is mainly driven by the bandwagon effect to associate with aspiration group, differing from those more privileged consumers who may engage in conspicuous consumption to disassociate from the crowd. The moderating role of traditional Chinese cultural values is further examined. In addition, subjective norm is found to mediate the impact of conspicuous consumption on purchase intention of name-brand products, supporting the hypothesized bandwagon effect. Finally, theoretical contributions and strategic implications to marketing in emerging markets are discussed.

Examining Antecedents of Brand Loyalty on Sportswear: An Empirical Investigation of University Students in Hong Kong

To extend the current understanding of brand loyalty in the sportswear industry, this article discusses six factors that influence brand loyalty of university students towards the Hong Kong sportswear market. Conclusions were drawn based on responses collected through online questionnaires. A total of 205 college students participated in the study. The final results showed that only product quality and brand name affect Hong Kong university students’ brand loyalty towards sportswear. However, based on the whole study, other factors (i.e., service quality, store environment, style and promotions) also play a vital role in sportswear marketing. This research provided insight for sportswear marketers in creating proper marketing strategies for the sportswear industry.

Evaluating Facebook brand content popularity for service versus goods offerings

Marketers using social media are struggling with its successful implementation, specifically in engaging their audiences through creation of popular brand content. Yet, creating popular brand content can lead to positive financial and brand outcomes. This research examines Fortune 500 companies' brand content strategies that contribute to Facebook content popularity metrics (i.e., number of likes and comments) for service versus goods offerings. Building on psychological motivation theory and the noted differences in culture and capabilities between goods and service firms, the article analyzes the key differences in service and goods brand content strategies in terms of branding, message appeals, and vividness. The findings from a multivariate multilevel Poisson model show that the use of corporate brand names is more popular for service messages whereas the use of product brand names, images, and videos is more popular for goods messages. Furthermore, service messages generate a higher number of comments than goods messages.

Readability and Comprehensibility of Patient Information Leaflets for Antidiabetic Medications in Qatar.

Background:The readability and comprehensibility of the patient information leaflets (PILs) provided with antidiabetic medications are of questionable standards; this issue negatively affects adherence to drug therapy, especially in patients with limited literacy skills. Objective: To evaluate the readability and comprehensibility of PILs supplied with medications used for the treatment of type 2 diabetes mellitus in Qatar. Methods: All PILs of the antidiabetic medications in Qatar were evaluated using the Flesch Reading Ease (FRE) score for readability. The Flesch-Kincaid Grade Level, Gunning-Fog Index, and SMOG Grading were used to estimate the comprehensibility of PILs in terms of school grade levels. Results: A total of 45 PILs were evaluated: 32 (71.1%) PILs of brand-name products and 13 (28.9%) for generics. Nine (20%) of the PILs were in English only; 8 (17.8%) were in English, Arabic, and French; and 28 (62.2%) were in English and Arabic. The mean FRE score was 37.71 (±15.85), and the most readable PIL had FRE score of 62. The mean scores for the comprehensibility evaluations were 10.96 (±2.67), 15.02 (±2.52), and 11.41 (±1.6) for the Flesch-Kincaid Grade Level, Gunning-Fog Index, and SMOG Grading, respectively. The most commonly used antidiabetic medication was metformin with 1372.9 (±552.9) as PILs' mean number of words. Conclusion: Only 2.2% of PILs had acceptable readability scores. All PILs could be comprehended by at least an 11th grade student, which exceeds the recommended grade level for health-related materials. Approximately 20% of these PILs were in English only and were not readable by most patients.

The impact of Australian legislative changes on synthetic cannabinoid exposures reported to the New South Wales Poisons Information Centre

BackgroundThe emergence of new psychoactive substances (NPS), including synthetic cannabinoid receptor agonists (SCRAs) poses novel challenges for drug regulation and public health. Misconceptions of safety and legality, coupled with the fact that NPS are undetectable on routine drugs screens contributes to their popularity. Concerns over the unpredictable toxicity and abuse potential of NPS has led to a variety of legislative responses worldwide. We wish to describe Australian trends in SCRA use, examining the effects of legislative changes on calls to Australia’s largest poisons centre. MethodsA retrospective review of calls to the New South Wales Poisons Information Centre (NSWPIC). Cases occurring between 1 January 2010 and 30 June 2015 with documented use of SCRAs were included. ResultsThere were 146 exposures to SCRAs recorded in the NSWPIC database. Federal bans of specific SCRA compounds in 2011/2012 had little impact on call volumes. State-based legislation introduced in 2013 banning specific brand names of SCRA products was followed by a dramatic, sustained decrease in exposures. The most common symptoms reported with SCRA use were tachycardia, vomiting, drowsiness, anxiety/panic, decreased level of consciousness, chest pain, agitation, hallucinations, confusion, seizures and hypertension. ConclusionBanning of specific brand names of SCRA (timed with raids and social media campaigns) appears effective at reducing SCRA exposures. We postulate that this raised awareness within the community of the illegality of these substances while also reducing supply through bricks-and-mortar shops. These results could help inform future legislative responses.

Pharmaceutical Patent Wars, Reverse-Payment Settlements, and Their Anticompetitive Effects for Consumers

Generic drugs have been provided considerable cost-savings to consumers. The Hatch-Waxman Act provides economic incentives to both generic and brand-name manufacturers, but it is a complicated piece of legislation scattered across numerous sections of the United States Code. This obfuscation has led to abuse by brand name and generic drug manufacturers, resulting in anticompetitive behaviors for the consumer. Despite attempts to ameliorate the problem, a review of case law makes plain that the judicial and legislative systems are currently inadequate to address this problem. Litigation typically arises in the context of patented drug filings after a generic drug manufacturer files an Abbreviated New Drug Application for a generic drug modeled after the patented drug, an act of constructive patent infringement. This then initiates paragraph IV patent litigation. In order to avoid a finding of patent invalidity, branded and generic manufacturers have entered into collusive “reverse-payment” agreements in which the branded manufacturer agrees to pay the generic company to stay out of the market. While direct cash payments seem to have been foreclosed in FTC v. Actavis, subsequent iterations of reverse payments have evaded this holding, allowing reverse payments to continue to the frustration of many consumers. Finally, the latest mode of manipulation does not involve monetary transfers, but rather manipulates the FDA system via product hopping, risk evaluation monitoring systems, and sham citizen petitions, to achieve anticompetitive aims. This articles examines the patenting system for generic drugs, the numerous modes of reverse-payment, particularly with the difficulty of prescribing a bright-line approach to often fluid definitions of “reverse payments.” This is the first article to review the array of reverse payment modes, explaining how legislative and judicial efforts to combat these practices have failed, and arguing for a systemic legislative approach to solving this problem.

Comparative Bioavailability of Two Oral Perampanel Formulations in Healthy Subjects: A Randomized, Open Label, Single-Dose, 2-Way Crossover Study

Background: Perampanel is a glutamate non-competitive receptor antagonist that is effective as adjunctive treatment for epilepsy. No studies regarding comparative bioavailability between a generic perampanel formulation and the brand-name product have been published in the literature. Therefore, the goal of the present investigation was to compare the bioavailability and to evaluate the bioequivalence between a novel pharmaceutical equivalent 12 mg film-coated tablet formulation and the reference product. Methods: An open label, randomized-sequence, two-period, two-treatment, single-dose, crossover design study in healthy volunteers(n=24) was conducted. The treatment was split out by a 42 days wash-out period. The informed consent was signed by all volunteers. Healthy subjects of both genders, including non-pregnant and nonlactating females between 21-55 years with Quetelet index between 19-29 kg/m2 were enrolled. Blood samples were withdrawn in vacutainers with EDTA over 168 h and plasma levels of perampanel were measured by HPLC/ fluorescence method. Pharmacokinetic (PK) variables (Cmax, AUC0-last, and AUCinf) after a single oral administration dose of the test and reference treatments were analyzed by a non-compartmental PK model using natural logtransformed data and were compared by ANOVA for a two-treatment crossover design. Bioequivalence between the two formulations was evaluated using the 90% Confidence Interval (CI) comprised between 80-125% corresponding to the ratio of the geometric means for log-transformed PK parameters. Results: A similar bioavailability between products was determined. Test and reference formulations showed no statistically significant differences in relation to the fixed effect of period, sequence, treatment and volunteers within sequence as random effect for PK variables. The estimated point and 90% CI of the ratios of Cmax, AUC0-last and AUCinf were 0.92 (0.83-1.03), 1.04(0.98-1.10) and 0.98 (0.86-1.11), respectively. The formulations showed comparable safety and tolerability. Conclusion: The new pharmaceutical equivalent perampanel 12 mg film-coated tablet formulation was also bioequivalent to the reference product. Therefore, both drugs are interchangeable.

Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored.

Background. Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods. Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results. Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: 1.62 ± 0.90 versus 1.75 ± 0.92 mg/dL (p < 0.001). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion. Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians.

It Is Safe to Change Horses in the Midstream - 3-Year Experience of Treating CML Patients with Imatinib Generics

▪Introduction. The substitution of brand-name drugs with cheaper generics is a modern tendency in health-care to decrease the burden on government budget and improve access to efficient treatment. Worldwide, generics have to be identical to the original drug in terms of pharmaceutical (active ingredients) and biological (pharmacokinetic) properties. Unfortunately, in Russia, as in most countries, there are no government regulations of equivalency to a brand-name product regarding dosage, strength, route of administration, quality, performance, and intended use. In Russia, since August 2012 the original Imatinib has almost fully been substituted with generics for the treatment of chronic myelogenous leukemia (CML).Aim. To assess tolerance and efficacy of Imatinib generics in terms of response durability by comparing it with that achieved previously in CML patients, who had received treatment with original Imatinib before switching to the generics.Materials and methods. Seventy-nine CML patients treated initially with original Imatinib (Novartis AG) with median treatment duration of 6.5 years (range, 0.5-11 years) were switched to generic drugs. The drugs: 1) GenericPh 100 mg, in capsules (Ph-Syntez, Russia) - 54 patients (44 with complete cytogenetic response (CCyR), including 32 with major molecular response (MMR); 2) GenericG 100 mg, in tablets (Laboratorio TUTEUR S.A.C.I.F.I.A., Argentina) - 25 patients (22 with CCyR, including 19 with MMR). In case of loss of response, besides non-compliance, we changed treatment to second-generation tyrosine kinase inhibitors (TKI2). Switching from one generic to another was made due to intolerance. We analyzed the range and frequency of adverse events (AE) and durability of responses achieved previously (hematologic, cytogenetic and molecular). IRIS data1 was used as a comparator for AE frequency during long-term Imatinib treatment. Statistical analysis included the Fisher exact test.Results. Tolerance of Imatinib generics was good with few exceptions. One patient in the GenericPh group suffered severe edema and was switched to Nilotinib with AE resolution. In the GenericG group 4/25 (16%) patients had severe gastroenterological toxicity (nausea, vomiting, abdominal distension, diarrhea) and were successfully switched to GenericPh. This might have been caused by the tablet filler (lactose) and related to concomitant lactose insufficiency in these patients. One patient had frequent infectious complications. Having stable deep molecular response, she entered the treatment free remission phase and had successful molecular response for more than two years. The frequency of other AEs is presented in Table 1. No significant differences were revealed between the generics and the original Imatinib in comparison with IRIS results. However, only 25% (20) of patients were free of any AE.No progression to AP/BC during the generics treatment was observed. Three deaths were registered (CML-related 1, blastic phase on Dasatinib treatment, the patient had only partial cytogenetic response to Imatinib and was switched to Dasatinib, with progression after 2 years on Dasatinib; cancer -1, cardiovascular disease -1). The patients who had inadequate responses to Imatinib before and after switching on generics were subsequently switched to TKI2: GenericPh - 11 patients (Nilotinib - 9 (CCyR - 8, MMR-7), Dasatinib - 2 (no CCyR with progression - 1, complete hematologic response -1)); GenericG - 3 patients (Nilotinib - 2, both with CCyR and MMR, Dasatinib - 1 -hematologic response with non-compliance). Durability of previousresponses was as follows: 4 patients lost their MMR: 3/54 (5.6%) while taking GenericPh and 1/25 (4%) - GenericG; 3 patients lost their CCyR: 2/54 (3.7%) while taking GenericPh and 1/25 (4%) - GenericG. All those patients were subsequently switched to TKI2 (3 re-achieving previous MMR and 1 demonstrating non-compliance). At the time of analysis there were still 58 (73%) patients on the generics treatment. 57 patients had CCyR and MMR, and one was not cytogenetically evaluated due to non-compliance (BCR-ABL 0.102%).Conclusion. No significant differences between the generics studied and the original Imatinib were observed in terms of their efficacy or tolerability in CML patients who were previously treated with a brand-name drug and subsequently switched to generics. [Display omitted] DisclosuresShuvaev:Novartis pharma: Honoraria; Pfizer: Honoraria; BMS: Honoraria. Fominykh:Novartis Pharma: Honoraria; BMS: Honoraria.

The Devil Is Not As Black As He Is Painted - 3-Year Experience of Treating Newly Diagnosed CML Patients with Imatinib Generics

▪Introduction. A generic drug is a pharmaceutical drug considered to be equivalent to a brand-name product. A generic drug has to contain the same active ingredients as those of the original formulation. Regulatory agencies used to require that generics be identical to their brand-name counterparts with regards to pharmacokinetic properties. In most cases, generic products are available after the patent protection given to a drug's original developer expires. In Russia, a patent protection lasts for a 10-year period from registration of the original drug. To this day, twelve Imatinib generics have been registered in Russia.Aim. To assess the safety and efficacy of Imatinib generics for treatment of newly diagnosed Chronic myelogenous leukemia patients that have been in our center since August 2012.Materials and methods. 30 newly diagnosed CML patients were started on generics. The drugs: 1) GenericPh 100 mg, in capsules (Ph-Syntez, Russia); 2) GenericG 100 mg, in tablets (Laboratorio TUTEUR S.A.C.I.F.I.A., Argentina); 3) GenericIm 100 mg, in tablets (Sandoz d.d. (Slovenia). Switching from one generic to another was done due to intolerance. We analyzed the range and frequencies of adverse events (AE), cumulative incidences of complete hematologic (CHR), major cytogenetic (MCyR), complete cytogenetic (CCyR), and early molecular responses (BCR-ABL<10% by IS), as well as the rate of BCR-ABL<1% by IS, major molecular (MMR) and molecular 4.0 log (MR4.0, BCR-ABL<0.01% by IS) responses at time-points according to the National CML diagnostic and treatment guidelines. The response rates were assessed only in regard to the generic treatment (with death, progression and switching to second-generation inhibitors as competing risks). Statistical analysis included descriptive statistics and cumulative incidence function.Results. Duration of the treatment with generics was 7-45 months, with a median of 13 months (GenericPh (27) + GenericG (2) + GenericIm (1)). No unexpected adverse events were observed during the Imatinib generics treatment. The generics tolerance did not differ from that of the original brand-name drug. Six patients were switched to second-generation tyrosine kinase inhibitors (TKI2) due to Imatinib intolerance. One patient progressed to blastic phase at 3 months after diagnosis. Three deaths were registered (1 - due to CML and 2 due to concomitant diseases). Overall survival rate was 90% and CML-related mortality - 3%. CHR at 3 months of the treatment was achieved in 93% of the patients. Cumulative response rates for cytogenetic and molecular responses are presented in Table 1. MR4.0 was registered in 23% of patients during overall treatment.Seven patients were switched to TKI2 due to insufficient efficacy of Imatinib. At the time of analysis 13 patients remained on Imatinib generics treatment: 12 patients with CCyR and 1 with PCyR, including 10 patients with MMR.Conclusion. Use of generics demands evaluation of its equivalency and control during its adoption into clinical practice. In terms of efficacy or tolerance no significant differences between the Imatinib generics studied and the original brand-name drug in newly diagnosed CML patients were found. [Display omitted] DisclosuresShuvaev:Pfizer: Honoraria; BMS: Honoraria; Novartis pharma: Honoraria. Fominykh:BMS: Honoraria; Novartis Pharma: Honoraria.

Comparative analysis of the cost and effectiveness of generic and brand‐name antibiotics: the case of uncomplicated urinary tract infection

Generic medications used for chronic diseases are beneficial in containing healthcare costs and improving drug accessibility. However, the effects of generic drugs in acute and severe illness remain controversial. This study aims to investigate treatment costs and outcomes of generic antibiotics prescribed for adults with a urinary tract infection in outpatient settings. The data source was the Longitudinal Health Insurance Database of Taiwan. We included outpatients aged 20 years and above with a urinary tract infection who required one oral antibiotic for which brand-name and generic products were simultaneously available. Drug cost and overall healthcare expense of the index consultation, healthcare cost during a 42-day follow-up period, and treatment failure rates were the main dependent variables. Data were compared between brand-name and generic users from the entire cohort and a propensity score-matched samples. Results from the entire cohort and propensity score-matched samples were similar. Daily antibiotic cost was significantly lower among generic users than brand-name users. Significant lower total drug claims of the index consultation only existed in patients receiving the investigated antibiotics, while the drug price between brand-name and generic versions were relatively large (e.g., >50%). The overall healthcare cost of the index consultation, healthcare expenditure during a 42-day follow-up period, and treatment failure rates were similar between the two groups. Compared with those treated with brand-name antibiotics, outpatients who received generic antibiotics had equivalent treatment outcomes with lower drug costs. Generic antibiotics are effective and worthy of adoption among outpatients with simple infections indicating oral antibiotic treatment. Copyright © 2016 John Wiley & Sons, Ltd.