Branded vs. Generic drugs: the role of self-perceived seriousness of disease

Purpose This study aims at exploring the role of perceived disease seriousness in consumers’ preference for generic versus branded drugs, by shedding light on new factors impacting consumer purchase behaviour for pharmaceutical products. Design/methodology/approach An exploratory study based on a quantitative analysis has been conducted with a sample of 100 participants who have been presented with two different scenarios: one related to more serious disease (as in cardiological disease) and one related to less serious disease (as in the seasonal flu). This paper considered Italy as a research setting where the recent mandatory prescription of the active ingredient by doctors leaves the final purchase decision in consumers’ hands Findings Results show that, although consumers are free to choose whether to buy a branded or a generic prescribed active ingredient, their choice is mainly driven by the role of the brand. Consumers’ intention to buy generic drugs is higher in the case of diseases perceived as less serious, while the intention to buy branded drugs is higher in the case of disease perceived as more serious. Originality/value This study contributes to marketing research and practice by proposing that consumers’ perceived seriousness of their disease should be considered as a further factor in identifying new marketing strategies in those contexts in which the choice between branded or generic drugs is free.

Characteristics and limitations of national antimicrobial surveillance according to sales and claims data

Purpose Antimicrobial use (AMU) is estimated at the national level by using sales data (S-AMU) or insurance claims data (C-AMU). However, these data might be biased by generic drugs that are not sold through wholesalers (direct sales) and therefore not recorded in sales databases, or by claims that are not submitted electronically and therefore not stored in claims databases. We evaluated these effects by comparing S-AMU and C-AMU to ascertain the characteristics and limitations of each kind of data. We also evaluated the interchangeability of these data by assessing their relationship. Methods We calculated monthly defined daily doses per 1,000 inhabitants per day (DID) using sales and claims data from 2013 to 2017. To assess the effects of non-electronic claim submissions on C-AMU, we evaluated trends in the S-AMU/C-AMU ratio (SCR). To assess the effects of direct sales of S-AMU, we divided AMU into generic and branded drugs and evaluated each SCR in terms of oral versus parenteral drugs. To assess the relationship between S-AMU and C-AMU, we created a linear regression and evaluated its coefficient. Results Median annual SCRs from 2013 to 2017 were 1.046, 0.993, 0.980, 0.987, and 0.967, respectively. SCRs dropped from 2013 to 2015, and then stabilized. Differences in SCRs between branded and generic drugs were significant for oral drugs (0.820 vs 1.079) but not parenteral drugs (1.200 vs 1.165), suggesting that direct sales of oral generic drugs were omitted in S-AMU. Coefficients of DID between S-AMU and C-AMU were high (generic, 0.90; branded, 0.84) in oral drugs but relatively low (generic, 0.32; branded, 0.52) in parenteral drugs. Conclusions The omission of direct sales information and non-electronically submitted claims have influenced S-AMU and C-AMU information, respectively. However, these data were well-correlated, and it is considered that both kinds of data are useful depending on the situation.

Examining therapeutic equivalence between branded and generic warfarin in Brazil: The WARFA crossover randomized controlled trial

Objectives To determine whether the generic and branded warfarins used as anticoagulants in Brazil are therapeutic equivalents based on their international normalized ratio (INR) results. Methods This crossover randomized controlled trial had four periods. We used the branded Marevan and two generic versions of warfarin sodium tablets, manufactured by União Química and Teuto laboratories, all purchased from retail drugstores. Eligible participants were outpatients from an anticoagulation clinic at a university hospital in São Paulo, Brazil. They had atrial fibrillation or flutter and had been using warfarin for at least 2 months with an INR therapeutic range of 2.0–3.0. Randomization was by numbered, opaque, sealed envelopes. Healthcare personnel and outcome assessors were blinded to treatments, but patients were not. The primary outcome was the variability in the INR (ΔINR) and secondary outcomes included mean INR. We accepted formulations as equivalent if the 95% confidence interval (CI) of the comparison of ΔINR between branded and generic formulations was within the limit of ±0.49. Results One hundred patients were recruited and randomized to six sequences of treatment (four sequences with n = 17 and two sequences with n = 16). União Química generic warfarin had equivalent variability in the INR to Marevan (ΔINR +0.09 [95% CI -0.29 to +0.46], n = 84). Comparison between Teuto generic warfarin and Marevan was inconclusive (ΔINR +0.29 [95% CI -0.09 to +0.68], n = 84). Conclusions Marevan and União Química warfarin had equivalent therapeutic effectiveness and both could be confidently used for anticoagulation. The comparison between Marevan and TW was inconclusive and does not warrant a statement of equivalence. Our methods are especially important for comparing generic and branded drugs that raise concerns and may be subject of future investigations by regulatory agents. Trial registration ClinicalTrials.gov NCT02017197.

Biosimilar bidding in centralized tenders in Norway

Our objective is to study the competition effect of biosimilar entry in centralized tenders for an expensive category or drugs - TNF-inhibitors. We use monthly observations of prices and volumes for all brands and biosimilars in this drug category in Norway, covering the period from Jan. 2006 to Dec. 2016. Descriptive statistics and regression models are used to investigate the impact of biosimilars on the drug price and the effect of the number of brands on the intensity of competition. Both the entry of biosimilars and new branded drugs have increased competition and reduced prices. According to our estimates, an increase in the market share of biosimilars from 10 % to 60 %, will be accompanied with a 50 % reduction in the expected price. Only two years after entry, the first biosimilars in this drug category had gained a market share of 40 % in Norwegian hospitals. Although entry barriers for biosimilars are higher than for generics of chemical substances, significant cost savings are expected from patent expirations of expensive biologics as well. The centralized design of the tenders is an important institutional factor behind the strong competition effect. Published: Online January 2020

Spectrophotometric method in comparative in vitro dissolution test of branded and generic ibuprofen tablets

The dissolution test is a simple and important in vitro method for assessing the bioequivalence, which aims to compare the bioavailability of generic and branded drugs. It implies the use of a proper apparatus (usually pharmacopoeially defined) in which the dosage form is dissolved, and the dissolution process itself is monitored/quantified using an appropriate analytical method among which high-performance liquid chromatography (HPLC) is widely used. Spectrophotometry could be a significant substitute, through its advantages in terms of simplicity and costs of analysis. In the present study, possible differences in bioavailability between branded and generic ibuprofen coated tablets were predicted using a dissolution test for solid dosage forms. The ibuprofen content and the amount of ibuprofen released in the dissolution test were determined using a simple spectrophotometric method. Based on the obtained results, no significant differences in the dissolution rate of ibuprofen from generic and branded coated tablets were observed. It can be concluded that the spectrophotometric method applied for the dissolution test, among other suitable methods, could be used for bioequivalence screening in conditions where rapid and simple assessment is required or where HPLC method is not available.

Acceptability and Perceptions of Generic Drugs among Patients, Pharmacists, and Physicians

Background: Generic drugs are the painstaking solution to deal with out of pocket expenditure however, the impact has not yet been seen in India. Thus, to understand the facilitators and barriers, this study aimed to gather evidence on the perception of the acceptability of generic drugs among patients, pharmacists, and physicians. Methods: The key informant interviews (KII) were conducted during 2017-2018 in Gujarat, India. A total of 25 (9 patients, 8 pharmacists, 8 physicians) KIIs were included in the thematic analysis. Results: Most of the patients knew about cheaper drugs are available in the market, but they perceived that those meant for poor people. Pharmacists talked about the profit from branded drugs are higher than generics. Pharmacist and doctors expressed concern for the efficacy of generic drugs, as it requires more visits to hospitals. Patients usually report more side effects if using generic drugs, apart from that poor packaging and lack of trust on generic also remained an issue in terms of satisfaction. Pharmacist and patients are both expressed their reliance on doctors suggestion and prescription; however, doctors are really not in favour to prescribe generics. The ethical dilemma remained with the pharmacists in not suggesting generics as an alternative to the branded drugs. Conclusion: The study concludes that cost is the main perception of patients, pharmacists, and physicians, however; the decision power lies with the pharmacist and doctors, which is mainly not in favour to use or promote the generic drugs even if the cost is low because of efficacy and satisfaction issues.

Generic drugs: a study on awareness among medical students and interns

Background: Use of generic drugs and its availability is one of the less discussed topics in the medical education but at the same time holds a lot of importance in providing affordable health care to the general public.Methods: All 150 II MBBS students and 80 interns who were willing were included in the study. After explaining the aims and objectives and obtaining the informed consent, a set of 14 semi structured questionnaire were given to the students through an online link. A total duration of 15 minutes was given to complete the questionnaire and submit to prevent bias.Results: Most of the students 98 (75.4%) believe that generic drugs are non-inferior to branded drugs compared to interns 33 (49.3%) who are still doubtful about its efficacy (p=0.0003). Most of the students 101 (77.7%) and interns 52 (77.6%) think that composition, dose and indications are same as branded drugs (p=0.987). 75 (57.7%) students and 25 (37.3%) of interns know that generic medicines are marketed only after the expiry of patent period of innovator drug (p=0.005). About 102 (78.5%) students and 44 (65.7%) interns prefer to prescribe generic drugs to their patients (p=0.061). Only 34 (26.2%) students and few interns 19 (28.4%) knew about jan aushadhi sugam app (p=0.744).Conclusions: Lack of awareness about the jan aushadhi sugam app and location of nearby generic stores was acting as the main hindrance in optimal utilization of generic drugs.