Brand-name drug manufacturers can market or license authorized generics (AGs), which are the same product sold under a generic name. By contrast, independent generics (IGs) are made by other ...manufacturers. The brand-name manufacturer of entacapone, a treatment for Parkinson’s disease, established 4 AGs before IGs emerged. We used this case study to understand how AGs can affect the length of brand-name exclusivity and robustness of generic competition.
Using public Food and Drug Administration and court records, we identified the regulatory and legal history for generic entacapone products marketed through 2021. We used Medicare Part D data to estimate trends in use, prices, and spending on entacapone products from 2011 to 2020, comparing actual spending with projected spending if IG competition had begun after expiration of the key patent protecting entacapone (October 2013) and prices had fallen consistent with levels observed for other generic drugs.
From 2012 to 2014, 3 potential entacapone IG manufacturers instead launched AG versions after settlement agreements with the brand-name manufacturer; the brand-name manufacturer additionally introduced its own AG. Four different IG versions were marketed beginning in 2015. From 2011 to 2020, average Medicare prices declined by 62%, less than the projected 74% to 92% price decline expected for a drug with 8 generics. Over this period, Medicare spent $1.1 billion on entacapone products, which could have been reduced by an estimated $137 to $449 million through typical IG competition.
The case of entacapone demonstrates how licensing multiple AGs in place of IG competition can increase spending. Government regulators should more rigorously monitor AGs to prevent such strategies.
•Authorized generics (AGs) are exact copies of a brand-name drug sold under the generic name by the brand-name manufacturer or its licensee.•In the case of entacapone, introduction of 4 AGs delayed independent generic competition, leading to an estimated $137 to $449 million in excess Medicare spending from 2011 to 2020.•Introduction of AGs in place of independent generics can reduce expected savings from generic competition.
Consider the following two (hypothetical) generic causal claims: “Living in a neighborhood with many families with children increases purchases of bicycles” and “living in an affluent neighborhood ...with many families with children increases purchases of bicycles.” These claims not only differ in what they suggest about how bicycle ownership is distributed across different neighborhoods (i.e., “the data”), but also have the potential to communicate something about the speakers’ values: namely, the prominence they accord to affluence in representing and making decisions about the social world. Here, we examine the relationship between the level of granularity with which a cause is described in a generic causal claim (e.g., neighborhood vs. affluent neighborhood) and the value of the information contained in the causal model that generates that claim. We argue that listeners who know any two of the following can make reliable inferences about the third: 1) the level of granularity at which a speaker makes a generic causal claim, 2) the speaker’s values, and 3) the data available to the speaker. We present results of four experiments (N = 1323) in the domain of social categories that provide evidence in keeping with these predictions.
Several cases of fatal enterocolitis have been described in association with the use of docetaxel (DTX), and this increase in adverse events has been concomitant with a change in formulation. Indeed ...in 2010, a new DTX-based presentation has been introduced in the form of a single ready-to-use vial by Sanofi-Aventis, presentation also used for generics. In this study, different available formulations were compared (Sanofi 2 vials, Sanofi 1 vial, Accord Healthcare, Kabi, Hospira) in terms of composition compliance with control specifications and simulated micelle behaviour to try to determine what could be the potential causes of this problem. This work had permitted to show that all the tested products complied with specifications in terms of dosage and purity. Variations in the composition of polysorbate 80 (PS80) have been observed but are probably too small to be responsible for the toxicity found in patients. However, we identified a difference in micelle size and release kinetics probably because of doubling concentration of ethanol in new formulation. As a result, we emphasised the importance in the case of DTX of conducting bioequivalence studies as expected in European Medicines Agency (EMA) guidance to ensure patient safety, even though these formulation changes might seem minor. Therefore, further studies are needed to explore the potential role of ethanol, PS80 and the unbound fraction of DTX in the development of enterocolitis in patients treated with DTX.
•In 2010, a new docetaxel-based presentation has been introduced in the form of a single ready-to-use vial by Sanofi-Aventis.•DTX generics enter the French market with compositions of excipients different from those of the branded product.•Many fatal cases have been attributed to enterocolitis and sepsis with a digestive starting point after docetaxel use.•All the tested products complied with specifications in terms of dosage and purity.•Formulation change of DTX complex parenteral solution should have led to a biowaiver study according to the EMA guidance.
In the perspective of the pharmaceutical industry development, manufacturers expand their product portfolios by updating generic drugs. Complex Generics (CG) or Nonbiological Generic Drugs (NBGD) ...contain known pharmaceutical substances are out of patent protection and are made by using new technologies, excipients, nanocarriers, dosage form modernization, etc. These drugs are developed in the patients’ interests to improve their life quality and increase drugs’ efficacy and safety. The article discusses the categories and characteristics of CG, shows examples available on the pharmaceutical market, API and dosage forms. This article discusses approaches to quality control that pose challenges for developers and regulators. The fundamental importance of the innovative drugs manufacturing process and the ingredients standardization in the dosage forms formulations to create the standard product are indicated. First, a comprehensive control of polymers is required as an important tool to make the necessary pharmacokinetics. The influence degree on the API release and the effectiveness of dosage form (DF) depends on the polymer’s physicochemical characteristics. In this regard, it is important to create databases of these excipients accessible to developers containing information about properties, use, dosages and safety. In view of the complexity structure and manufacturing processes of the NBGD and insufficiency of pharmacopeial requirements for standard approaches for resolving issues of comparability and bioequivalence the current regulatory documents should be expanded and revise for a correct quality assessment. There is a need to create new scientific and regulatory roadmaps for the development and approval of complex generic drugs.
Abstract
Some generic sentences seem to be true despite the fact that almost all the members of the relevant kind are exceptions. It’s controversial whether generics of this type express relatively ...weak generalizations or relatively strong ones. If the latter, then we’re systematically mistaken about their truth, but they make no trouble for our semantic theorizing. In this brief note, I present several arguments for the former: sentences of the relevant type are weak generics.
Abstract The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients’ and doctors’ loyalty to branded products. Loyalty to ...originator drugs, to the point where originator prices rise upon generic entry has been described as the ‘generics paradox’. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance.
The South African pharmaceutical market, like many other low- and middle-income countries, has long been synonymous with high medicine prices. In response to this, the government had instituted ...several policies to improve medicine pricing transparency and to lower medicine prices. Importantly among the new policies was the introduction of the single exit price mechanism and provisions for the increased uptake of generic medicines. Despite some early successes, the increasing presence of pseudo-generics in the South African pharmaceutical market appears to be hindering the process.
This study sought to describe the price differentials among the originator, pseudo-generics, and true generics registered in South Africa in an effort to create consumer and prescriber awareness of this phenomenon.
Private-sector medicine prices for the originator, pseudo-generics, and true generics were sourced from the South African Medicine Price Registry.
The study revealed that of most medicines with a true generic competitor (n = 10 of 14), the pseudo-generics were priced more than even the highest-priced generics.
The increasing presence of pseudo-generics in the South African pharma market warrants further oversight and consumer and prescriber awareness.
•The presence of pseudo-generics is increasing in South Africa without any benefit to patients.•Greater advocacy for the regulation of pseudo-generics is essential.•Prescribers and patients need to be more aware of the pricing and presence of pseudo-generics in South Africa.
Some generic generalizations have both a descriptive and a normative reading. The generic sentence “Philosophers care about the truth”, for instance, can be read as describing what philosophers in ...fact care about, but can also be read as prescribing philosophers to care about the truth. On Leslie's account, this generic sentence has two readings due to the polysemy of the kind term “philosopher”. In this article, I first argue against this polysemy account of descriptive/normative generics. In response, a contextualist semantic theory for generic sentences is introduced. Based on this theory, I argue that descriptive/normative generics are contextually underspecified.
Signed into law in August 2022, the Inflation Reduction Act includes provisions requiring the federal government to negotiate prices for medications covered under Medicare Part D. Initial ...negotiations will target drugs with the highest total spending and price increases relative to inflation. In this study, we identify dermatology prescriptions with the highest cost burden on Medicare Part D and analyze recent trends in total spending and unit costs.
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