Generics/Research

American College of Physicians makes new recommendations to cut drug spending

Generics/Research | Posted 10/01/2020

A paper from the American College of Physicians (ACP) makes a number of policy recommendations to reduce costs of prescription drugs in the US, including annual caps for out-of-pocket spending and negotiating with manufacturers [1].

The impact of generics regulation in Brazil

Generics/Research | Posted 13/12/2019

Sales of originator drugs have decreased and the number of generics manufacturers have increased following the introduction of the Brazilian Generics Law, reports a new study [1].

FDA generics approvals increasing but not for at-risk generics

Generics/Research | Posted 29/11/2019

Analysis of generics approvals by the US Food and Drug Administration (FDA) reveals a slight increase in the total number of applications approved between 2016 and 2018. Over 1,800 applications were approved in this time, however, there was no significant change to the proportion of these drugs in shortage or with limited competition [1].

Safety of generics in US questioned

Generics/Research | Posted 15/11/2019

US Food and Drug Administration (FDA) regulations guarantee a safe drug supply. However, author Michael White, from the Health Outcomes, Policy, and Evidence Synthesis Group, University of Connecticut School of Pharmacy, Connecticut, USA, questions the safety of foreign generic drug imports [1].

Generics transition brings economic benefits to Canada

Generics/Research | Posted 08/11/2019

Economic analysis of genericization of cancer medicines in Canada has confirmed their cost-effectiveness. This rare example of an economic evaluation of the benefits of generics was published in Current Oncology [1].

A call for economic reassessment of drug regimens

Generics/Research | Posted 08/11/2019

Canadian researchers have called for the cost-effectiveness of drug products to be routinely reassessed. Their study, published in Current Oncology [1], has shown that cost-effectiveness of products alters significantly after generics are introduced. This has big implications for healthcare budgets and access to medicines, in Canada and worldwide.

Pharmacy chain drives choice among US generics manufacturers

Generics/Research | Posted 25/10/2019

A recent study shows that the dispensing pharmacy chain is a strong driver of generics manufacturer choice in the US, which could have implications for economic models of the generic drugmarket [1].

First pregabalin generics approved by FDA

Generics/Research | Posted 18/10/2019

In July 2019, the US Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (pregabalin) for the management of fibromyalgia, postherpetic neuralgia, neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, and as adjunct therapy for partial-onset seizures in patients aged 17 years or over.

Strong generics nocebo effect found in US

Generics/Research | Posted 11/10/2019

In the US, generic drug products account for approximately 90% of all prescriptions dispensed [1]. Despite this, there is a continued lack of trust in these drug products. Generics are often perceived as less effective and less safe than their brand-name reference products. Now, researchers at Brigham and Women’s Hospital and Harvard Medical School have confirmed that in the US, generics exhibit a strong nocebo effect. Here, negative bias against generics leads to negative clinical outcomes [2]. The researchers call for more education about generics to increase awareness of their benefits and increase access to these lower-priced medicines.

New evidence: comparable clinical outcomes for generic and brand medications

Generics/Research | Posted 04/10/2019

New research carried out at Brigham and Women’s Hospital and Harvard Medical School, provides additional evidence that shows generic and brand-name drugs have comparable clinical outcomes [1].

Evaluating success: generics substitution policy in Chile

Generics/Research | Posted 27/09/2019

The effectiveness of Chile’s 2014 generics substitution policy has been assessed by an international team of researchers. In their BMJ Global Health [1] article, the authors reveal that, although there has been a decrease in the uptake of expensive originator drugs, this is not mirrored by an increase in the uptake of less expensive bioequivalent products. This shows that further work is needed to help increase the uptake of generics in Chile.

Generics in Chile: policy success but promotion required

Generics/Research | Posted 20/09/2019

A first-time evaluation [1] of Chile’s generics substitution policy has shown that there has been a decrease in sales of branded originator medicines since policy implementation in 2014. However, this was not mirrored by an increase in sales of the corresponding generic drug products. The BMJ Global Health [1] article authors note that, to improve access to medicines in Chile, more work needs to be done to promote the uptake of generics.

TRIPS flexibilities: current and future use in the SADC region

Generics/Research | Posted 13/09/2019

In response to the HIV/AIDS crisis of the late 1990s, several legal options were introduced to facilitate access to lower-cost treatments. These included flexibilities in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, known as ‘TRIPS flexibilities’. In a recent review, authors ‘t Hoen, Kujinga and Boulet describe TRIPS flexibilities and discuss their current and future use in the Southern African Development Community (SADC) region [1].

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].

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