Generics/Research

Improving access to medicines: the Doha Declaration on the TRIPS Agreement

Generics/Research | Posted 06/09/2019

In a recent review, authors ‘t Hoen, Kujinga and Boulet describe the role of the Doha Declaration on the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in improving access to essential medicines [1].

Patent challenges in the SADC region

Generics/Research | Posted 30/08/2019

High pharmaceutical prices restrict access to essential medicines. New medicines are often patent protected which sustains prices well above the cost of production. This problem was particularly apparent during the HIV/AIDS crisis in the late 1990s. At this time, 40 million people were believed to be infected with HIV in the developing world and only one in a thousand had access to the required antiretroviral medicines (ARVs). This situation led to conflicts regarding patents for HIV medicines, only a few years after the establishment of the World Trade Organization (WTO) and the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. TRIPS established international standards to protect intellectual property, including a 20-year patent protection for medicines.

Generic irbesartan is safe and effective, shows phase IV trial

Generics/Research | Posted 23/08/2019

Generic versions of the anti-hypertensive irbesartan are equally effective as their branded counterparts, finds a phase IV study conducted in Korea. The study also found that irbesartan is less effective in patients with a high body mass index (BMI) or a history of anti-hypertensive use, suggesting more intensive treatment may be needed in some patients [1].

Prices for infectious disease treatments and how to reduce them

Generics/Research | Posted 16/08/2019

A recent review from Harvard Medical School explores the factors fuelling high drug prices in the US, suggesting several ways to avoid exorbitant pricing, including increasing clinician awareness of healthcare costs [1].

Generic Drug User Fee Act is a benefit to the Indian pharmaceutical industry, study finds

Generics/Research | Posted 26/07/2019

The Generic Drug User Fee Act (GDUFA) has had positive effects on generics manufacturers in India, providing increased return on investment and encouraging compliance with US regulation, recent analysis suggests [1].

Adherence to generic versus brand-name statins and associated clinical and economic outcomes

Generics/Research | Posted 24/05/2019

Despite evidence supporting the efficacy of statins for the treatment and prevention of cardiovascular disease, a lack of adherence to statin treatment continues to be a major problem. Sicras-Mainar and colleagues investigated real-world treatment persistence and medical possession for generic versus brand-name statins used in routine clinical practice, and assessed associated clinical and economic outcomes [1].

Costs and prices of entecavir to treat Hepatitis B

Generics/Research | Posted 25/03/2016

In an analysis of the costs and target prices of Hepatitis B treatment entecavir, author Andrew Hill from Liverpool University, UK and colleagues from Imperial College London, UK and Howard University, Washington DC, USA investigated how use of generics is affecting the cost of Hepatitis B treatment around the world [1].

Mixed beliefs about generics among patients in a Malaysian hospital

Generics/Research | Posted 03/05/2019

The Malaysian Government is heavily subsidizing public healthcare expenditure in order to provide access to health care for all citizens. In 2017, total healthcare expenditure in the country was approximately 9.4% of the annual budget. In order to overcome the increasing cost of health care, the government has implemented a National Generic Medicine Policy in 2006 to promote healthier competition in medicine pricing and to make medicines more affordable to the general public. After 10 years of policy implementation, authors from the Ministry of Health Malaysia assess patients' beliefs about generics.

Market evolution of new drug formulations

Generics/Research | Posted 01/04/2019

Brand-name drug manufacturers sometimes create modified versions of their approved drugs which can include new strengths, dosage forms, or delivery routes. This product modification can meaningfully increase patient treatment options; however, some cases have come under scrutiny as they do not offer any clear therapeutic advantages. This second practice is a form of ‘product hopping’, a method used by manufacturers to prolong revenue streams related to market exclusivity. Complementary strategies such as product discontinuation can augment the impact of product hopping.

Factors associated with increased side effects and lower perceived efficacy when switching to a generic

Generics/Research | Posted 22/03/2019

In 2017, the New Zealand Pharmaceutical Management Agency (PHARMAC) changed the funded version of the antidepressant venlafaxine from Efexor XR (the branded originator) or Arrow-Venlafaxine XR (a generic version) to a new generic, Enlafax XR. MacKrill and Petrie examined differences in preferences and perceptions between patients switched from the originator branded venlafaxine to the new generic, and those switched from the old generic version [1]. Specifically, they investigated the factors associated with preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic.

Escalating prices of generic drugs in the US

Generics/Research | Posted 15/03/2019

Generic prescription drug prices have been escalating rapidly in the US. In 2014, generic drug prices increased by 38% on average. Public outcry has led to a flurry of legislative proposals, and two federal bills were introduced in 2017 to improve price transparency and identify drugs exhibiting outlier ‘price spikes’, however, both remain unenacted. In the first three months of 2018, 53 drug pricing transparency bills were initiated in 23 state legislatures.

The 700-dollar vitamin: excessive generics prices in the US

Generics/Research | Posted 01/03/2019

Authors from Johns Hopkins University School of Medicine discuss excessive prices for generics in the US, using vitamin K₁ as an example [1].

Impact of generic reference pricing on candesartan and rosuvastatin use in South Africa

Generics/Research | Posted 15/02/2019

Researchers from South Africa and The Netherlands investigated the effect that generics and generic reference pricing has on candesartan and rosuvastatin use in South Africa [1].

Safety of brand-name and generic angiotensin II receptor blockers

Generics/Research | Posted 18/01/2019

Authors of a study carried out in Canada found that there is still uncertainty regarding generics substitution of angiotensin II receptor blockers (ARBs) [1].

Effectiveness of chronic hepatitis C treatment using direct-acting antivirals: real-life data

Generics/Research | Posted 30/11/2018

Hepatitis is an inflammation of the liver and can be caused by medications, toxins, severe alcohol use and other medical conditions. Hepatitis can also be caused by viruses, most commonly hepatitis A, B and C. Both hepatitis A and B can be dangerous, but there are effective vaccines against both viruses, however, there is no vaccines for hepatitis C [1].

Higher generics use results in higher Medicare Part D star ratings

Generics/Research | Posted 16/11/2018

A study conducted by researchers from Auburn University and IMPAQ International has found that Medicare^# Part D* prescription plans with higher generics use have higher summary star ratings and improved member experience [1].

Ensuring a stable supply of APIs in Japan

Generics/Research | Posted 09/11/2018

A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). It is also indispensable for promoting the use of generics, because API distribution issues can lead to generics shortages. For instance, of the 46 drug shortage problems that arose in FY2013, 21 were associated with API shortages [1]. These shortages can result in a perception among medical staff and patients that generic drugs are unreliable. Therefore, minimizing the risk of API shortage is crucial for promoting the use of generics.

Individual pathways for development of complex generics

Generics/Research | Posted 02/11/2018

The downside of having clear regulatory standards for approval of pharmaceuticals, according to Rodrigo Cristofoletti from Brazil’s Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), is the overuse of one-size-fits-all (OSFA) approaches [1]. Although such approaches ensure harmonization throughout the regulatory decision-making process, they may not be adequate for all cases, and especially not in the case of complex generics.

Platelet reactivity with generic and brand-name clopidogrel

Generics/Research | Posted 19/10/2018

The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. However, there is a lack of information about inhibition of platelet reactivity by generic preparations. A study was therefore carried out using both generic and brand-name clopidogrel to compare the platelet reactivity [1].

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