Generics/Research

Japan’s drug shortage crisis: challenges and policy solutions

Generics/Research | Posted 23/10/2024

Drug shortages are worsening worldwide [1, 2], and Japan is facing significant challenges due to a combination of factors. One major issue arises from the shift from brand-name to generic drugs, coupled with scandals involving poor manufacturing and development practices. These shortages affect access to essential treatments, prompting calls for action from pharmaceutical companies and the government.

Saudi FDA drug approvals and GMP inspections: trend analysis

Generics/Research | Posted 22/05/2024

A GaBIJ Review Article entitled ‘Trends in Saudi FDA drug approvals and GMP inspections: an observational study’, was published by a group of authors, Alhomaidan et al., from Saudi Food and Drug Authority (SFDA) in October 2023 [1].

Generic medications in the Lebanese community: understanding and public perception

Generics/Research | Posted 23/01/2024

A study conducted by Hatem G and Itani R et al. found that factors such as regulatory standards and quality assurance can influence people’s perception of generic drugs. This research involved 385 patients recruited from six public healthcare centres in Lebanon. Like in many countries, the regulatory authority in Lebanon ensures that generic drugs meet the same standards as brand-name drugs.

Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study

Generics/Research | Posted 08/09/2023

A study conducted by Awada S et al. stated that several factors can contribute to a lack of knowledge among community pharmacists regarding the differences between biosimilar and generic drugs. According to the authors, understanding the scientific and regulatory aspects of biosimilars can be challenging, primarily due to the limited clinical experience in dispensing biosimilars, which leads to misconceptions about their characteristics [1].

Reshaping landscape of Japanese generics market – uncertain future of universal health insurance

Generics/Research | Posted 10/08/2023

According to a study conducted by Kosaka M et al., Japan established a national health insurance scheme in 1961. This scheme ensured that the entire Japanese population has equal access to medical care by paying only 10%–30% of the medical cost from their own pocket [1]. Despite the advancement of medical technology and a fast-ageing society, Japan’s healthcare costs have continued to rise. However, the Japanese government has failed to offer a fundamental solution and has instead implemented interim measures, with a notable example being the encouragement of generic drug utilization [2]. Similar issues and challenges have been observed in wealthy Organisation for Economic Co-operation and Development (OECD) Asian health markets [3].

Impact of e-bidding procurement on generic omeprazole injection prices in Thailand

Generics/Research | Posted 20/06/2023

To address Thailand's increasing drug costs, the government implemented e-bidding for drug procurement. In a study by Pentrakan et al., e-bidding reduced omeprazole injection prices by 17.35% per vial and enhanced the procurement process. Nonetheless, maintaining a balance between innovation and involving local suppliers is vital for success [1].

Trajectories of prices in generic drug markets

Generics/Research | Posted 06/04/2023

In a study by Trujillo AJ et al., the authors adopt a group-based trajectory modelling approach to analyse the price trends of generic drugs. The analysis is conducted using price data collected quarterly over the past decade from the IBM MarketScan claims database. The study focus is to understand the trajectory patterns of these drugs and identify factors that may have influenced their pricing over time [1].

Evaluation of pharmaceutical equivalency of manufactured generic drugs in UAE

Generics/Research | Posted 10/02/2023

Generic medicines are pharmaceutical products manufactured to be equivalent to the brand or innovator drug products. They represent the majority of worldwide prescribed medicines; therefore, their quality is critical to ensure equivalent therapeutic outcomes

New insights into the amount of R & D for new uses of generic drugs

Generics/Research | Posted 12/12/2022

Generic drugs are considered indispensable to healthcare systems because they are substantially cheaper than original versions of the drugs. These drugs have become common place, within healthcare delivery, because of the anticipated financial benefits [1].

Pricing and reimbursement of medicines in Canada

Generics/Research | Posted 02/09/2022

Canada is a wealthy country with gross domestic product (GDP) per capita of US$43,258 in 2020. It ranks 16th in the United Nations’ Human Development Index and is one of the most multicultural countries in the world. Canada’s population of more than 38 million includes a significant indigenous population. Its huge land mass means it is very sparsely populated outside urban areas. Authors from Canada and Brazil discuss the pharmaceutical pricing and reimbursement policies in Canada [1].

Medicines pricing conditions in Italy and Brazil: comparison of regulations

Generics/Research | Posted 26/08/2022

In the context of the National Health Services (NHS), the gearing that moves the health services comprises a legal framework, permeated by technical and economic parameters.

Relevance of NTI to the treatment of epilepsy

Generics/Research | Posted 01/07/2022

In a mini review, author a Roy G Beran discusses what is the relevance of a narrow therapeutic index (NTI) to the treatment of epilepsy [1].

What is the meaning of a narrow therapeutic index?

Generics/Research | Posted 17/06/2022

What is the meaning of a narrow therapeutic index (NTI) is a topic explained by author Roy G Beran, in a mini review [1].

Consequences of generics being favoured by healthcare providers

Generics/Research | Posted 03/06/2022

Generics are favoured by healthcare providers due to a variety pf reasons, according to author Roy G Beran [1].

What is meant by a generic medication and generic equivalence?

Generics/Research | Posted 10/06/2022

Author Professor Roy G Beran, in a mini review, explains what generics are and what is meant by generic equivalence [1].

The cost of developing drugs and use of generics

Generics/Research | Posted 27/05/2022

In a mini review, author Professor Roy G Beran explains how generics can be produced at a much lower cost than originator drugs [1].

Re-evaluation of the use of generics, especially when treating conditions such as epilepsy

Generics/Research | Posted 20/05/2022

Regulatory bioequivalence rules for generics are well established and recognized. However, proving bioequivalence may not always be so easy, especially with drugs with a narrow therapeutic index (NTI) [1].

Repurposing generic drugs can save time and money

Generics/Research | Posted 16/05/2022

Repurposing generic drugs for new indications could save time and money compared to developing new treatments and represent a cost-effective way of addressing unmet medical needs, argues a new article by a University of Michigan professor [1].

Availability of medicines and the sustainable development of the national health system in Russia

Generics/Research | Posted 06/05/2022

The modernization of the drug supply system for citizens as a multifaceted process that ensures the sustainable development of the national health system is the focus of attention of the economy, the state and society. In order to study this, authors from Russia carried out a study to analyse the availability of medicines for the population for the treatment of cardiovascular diseases in 2011 and 2019 [1].

Generic etoricoxib is equivalent to the reference drug

Generics/Research | Posted 04/03/2022

A study comparing generic etoricoxib (ETO) to the originator drug Arcoxia [1] finds that the generic version of the drug is bioequivalent to the reference compound, according to the Association of Southeast Asian Nation (ASEAN) bioequivalence guidelines.

Call for drug pricing transparency

Generics/Research | Posted 05/11/2021

By 2023, pharmaceutical expenditure is expected to reach US$1.5 trillion [1]. This causes significant strain on healthcare systems worldwide and work is underway to bring pharmaceuticals’ spending down.

High price of cancer medicines make treatment unaffordable globally

Generics/Research | Posted 29/10/2021

Cancer is the leading cause of death worldwide. Currently, there are increasing concerns about the price of cancer medicines and how this can limit patient access to lifesaving treatments. Now, a new study published in Applied Health Economics and Health Policy [1] calls for strengthened pricing policies that can ensure affordable cancer treatment for all.

US brand-name drug market exclusivity periods remain relatively unchanged over the past decade

Generics/Research | Posted 22/10/2021

The passage in 1984 of the Hatch-Waxman Act set into motion sweeping changes to the US brand-name and generic drug competitive environment. It greatly increased generic drug competition for small-molecule drugs, by establishing a new abbreviated new drug application (ANDA) generic drug approval process that substantially reduced the time and cost associated with a generic drug marketing application submitted to the US Food and Drug Administration (FDA). In addition, it created incentives for challenges to brand-name drug patents, while also creating incentives for continued medical innovation and new drug development by drug innovators.

Considerations for the evaluation of generic IUDs containing levonorgestrel

Generics/Research | Posted 15/10/2021

Fertility regulation benefits the population, protecting the right to life and health, supporting the right of individuals to enjoy their sexuality and the right of children to be born wanted. In addition, it safeguards people’s freedom of conscience to decide whether or not to use a contraceptive method, based on their personal values, safeguards the principle of non-maleficence and the principle of equity and justice. This is fulfilled when services are universally accessible without discrimination and authorities monitor that this condition is respected. Currently, different types of contraceptive methods are available, which are classified into hormonal, barrier, long-acting reversible contraception, emergency contraception and sterilization. All of them must meet the basic conditions of efficacy, safety, acceptability, availability and reversibility.

Generic pharmaceutical policies in the MENA region

Generics/Research | Posted 17/09/2021

Healthcare systems in the Middle East & North Africa (MENA) region face challenges in service funding and delivery with policy emphasis in the region currently focused on controlling pharmaceutical expenditure. A key component of pharmaceutical cost-containment is a strong policy for generics aiming to improve uptake and access.

The generics market in Brazil

Generics/Research | Posted 16/07/2021

The Brazilian pharmaceutical market has undergone many changes since the introduction of generic drug laws.

Laws on packaging, substitution and prescription of generics in Brazil

Generics/Research | Posted 09/07/2021

According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.

Legal requirements on equivalence studies for generics in Brazil

Generics/Research | Posted 02/07/2021

The creation of the legal system for generic medicines began with the introduction of Law Number 9787 in February 1999 (Brazil 1999). According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.

Backlog of drug patents in Brazil

Generics/Research | Posted 25/06/2021

In an article on ‘How much does the backlog on drug patents cost for health in Brazil?’, Jannuzzi et al. in 2017 [1] showed backlogs in the analysis of patent applications in Brazil. These delays, known as ‘backlogs‘, extend the term of patents granted on medicines and delay the entry of generics into the market.

Technological approaches to drug repurposing for cancer treatment

Generics/Research | Posted 02/04/2021

Cancer is one of the leading causes of death in the world today, causing nearly 10 million deaths in 2018 alone. Despite extensive research into new treatments, when these eventually reach the market, they are often very expensive. The strategy of drug repurposing is being applied to identify already approved drug products as potential cancer therapies. This can bring new cancer treatments to patients faster and at a lower price. A review, published in Signal Transduction and Targeted Therapy [1], summarizes approaches used for drug repurposing and discusses the main barriers to uptake.

Non-profit generics manufacturers in the US reduce foreign dependence

Generics/Research | Posted 11/06/2021

Non-profit generics drug manufacturers have the potential to make important contributions to reduce foreign dependence on generic drugs in the US, argues an article published in The Journal of Law Medicine and Ethics [1].

More out-of-pocket costs for US patients with rising prescription drug prices

Generics/Research | Posted 31/05/2021

Increasing prices of brand-name drugs in the US, leaves patients with increasing costs at the pharmacy, says a study published in JAMA Network Open [1].

Difficult-to-make drugs meet US quality standards

Generics/Research | Posted 14/05/2021

Difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the country, finds a study published in JAMA Network Open [1].

New in vitro–in vivo simulations predict generic bioequivalence

Generics/Research | Posted 07/05/2021

If we can predict the outcome of bioequivalence studies in the generic drug development process, we can save time and money. Now, a new in vitro–in vivo simulation (IVIVS) approach to predict the in vivo outcome of these studies, published in Materials [1], has been developed by researchers National and Kapodistrian University of Athens.

Dispensing branded drugs costs Medicare over a billion dollars

Generics/Research | Posted 09/04/2021

Branded drugs dispensed instead of generics at the request of physicians and patients have incurred annual costs of over US$1 billion to the Medicare programme. and US$270 million to patients, reveals a study published in JAMA Network Open [1].

Debate about generic versus brand-name drugs for glaucoma

Generics/Research | Posted 19/03/2021

Glaucoma is a chronic, largely asymptomatic disease that often needs lifelong treatment. The choice of drugs is extremely important as the cost of drugs; side effects and efficacy often affect compliance and adherence to therapy. For a given class of drug, there are three options including brand-name drugs, generics and branded generics. Brand-name drugs are costlier compared to generics and branded generics because they are originator molecules developed by a company after many years of research and come into the market with a patent. Whereas branded generics are produced by a different company once the patent of the originator company expires. Moreover, competition amongst different companies to make the similar formulation of branded generics further reduces the cost.

The role of authorized generics in improving access to medicines

Generics/Research | Posted 05/03/2021

In recent years, many authorized generic drug products have been launched by pharmaceutical companies at lower prices than their brand-name originators. A recent viewpoint, published in JAMA Internal Medicine [1], discusses the ways that authorized generics are launched in the US. It also considers whether these products improve lower costs and access to medicines.

Approving generics of polymer-based parenteral long-acting drugs

Generics/Research | Posted 26/02/2021

To assure the safety and the efficacy of drugs, quality and batch-to-batch reproducibility need to be guaranteed. In the case of parenteral long-acting products, the regulatory authorities in the European Union (EU) and the US deviate in their guidance, differences include how to define such products and in vitro release assays.

Adherence improves long-term prognosis and medical costs in Japan

Generics/Research | Posted 19/02/2021

Medical costs and the burden associated with cardiovascular disease are on the rise. In Japan, due to changes in lifestyle and other factors, the number of inpatients with cardiovascular disease and other conditions is increasing at a rate of 10,000 per year.

Anti-competitive strategic patenting by pharmaceutical companies

Generics/Research | Posted 12/02/2021

Drug prices have considerably increased in recent years, affecting healthcare budgets and posing a serious risk to the affordability and accessibility of medicines for society [1]. Various reasons for high drug prices are put forward by pharmaceutical companies, including the complexity of drug discovery and development, as well as the expensive and lengthy regulatory procedures involved [2]. While these reasons may play an important role in this regard, some practices by pharmaceutical companies substantially contribute to this problem.

Perspectives of prescribing practices in public health facilities in Eswatini

Generics/Research | Posted 15/01/2021

Rational medicines use (RMU) is the prescribing/dispensing of good quality medicines to meet individual patient’s clinical needs. Policymakers, managers and frontline providers play critical roles in safeguarding medicine usage thus ensuring their rational use. Therefore, in order to investigate this, researchers carried out a study investigating the perspectives of key health system actors on prescribing practices and factors influencing these in Eswatini [1]. Public sector healthcare service delivery in the region is carried out through health facilities (public sector, not-for-profit faith-based, industrial) and community-based care.

Familiarity with substitution of prescription generics increases positive attitudes toward OTC generics

Generics/Research | Posted 11/12/2020

Introduction of measures to stimulate increased sale of generics swept over the Nordic countries in the 2000s. In Sweden, in 2002, generics substitution for reimbursed prescription drugs was made mandatory and the switching rates rose over the years to reach almost 100%. Although generics policies seem to be reserved for the prescription drug market [1], a contagion effect has been observed in the market for over-the-counter (OTC) drugs. Soon after the Swedish state monopoly on the sale of pharmaceutical products was terminated and new measures to boost sales of generic prescriptions was put in place in 2009, new generic brands of the top-selling OTC analgesics emerged on the market, all with a lower price compared with previously established brands [2]. Since OTC drugs are usually excluded from pharmaceutical benefit schemes, it is reasonable to expect a demand for cheaper brands when such options exist. Albeit, time has shown that the original brands often hold their position as OTC market leaders.

Cost savings after switching to generic tacrolimus

Generics/Research | Posted 04/12/2020

The use of narrow therapeutic index generic immunosuppressant in solid organ transplantation is controversial. This is because drugs with a narrow therapeutic index, such as immunosupressants, are defined by a narrow distance between the dosage that induces a desired effect and that dosage which already has a toxic effect [1]. This has led to medical and scientific societies being reluctant to switch to generics of these types of drugs because they think that small pharmacokinetic differences could predispose episodes of acute rejection or of adverse effects derived from toxicities of the product [2, 3].

Equivalent adherence with brand and generic osteoporosis treatments

Generics/Research | Posted 27/11/2020

Osteoporosis patients are just as likely to adhere to a generic bisphosphonate treatment as they are to a brand-name product, reveals a new study published in Scientific Reports [1].

Pharmacokinetics and generic drug switching: a regulators view

Generics/Research | Posted 13/11/2020

Researchers from the Netherlands share their view on the pharmacokinetic aspects of generic drug switching, from a regulatory perspective. They argue that there is no reason to change the current average bioequivalence-based approval pathway for generics [1].

Medicare Part D favours generics over brand-name drugs

Generics/Research | Posted 23/10/2020

A recent assessment of Medicare Part D [1] finds that insurance plans favour generic drugs over innovator products. Fewer than 1% of plans covered only the brand-name version of a drug in 2019.

Out-of-pocket spending caps cut patient spending by a third

Generics/Research | Posted 02/10/2020

Out-of-pocket spending caps on specialty drugs in the US have reduced spending by 32% for some patients, finds a new study of almost 30,000 specialty drug users [1].

Evaluating reasons for US low generics substitution rates

Generics/Research | Posted 11/09/2020

The uptake of generic drug products in the US has not met expectations despite their widespread availability and relatively low cost. A team of researchers based at Johns Hopkins University in the US, have now investigated the reasons for generics utilization and substitution across therapeutic classes. They reveal marked variation in reasons, with women less likely to substitute for generics, those using mail order pharmacies less likely to substitute, and state specific laws having little influence.

Generics substitution in Finland: a pharmacy dispenser perspective

Generics/Research | Posted 28/08/2020

In Finland, mandatory generic drug substitution was adopted in 2003 [1]. This is overseen by pharmaceutical staff who give advice to patients and decide which drug products they should receive. A recent study by Ranio et al. assessed the content of patient counselling about interchangeable medicines and generics substitution in Finnish community pharmacies [2].

Study reveals link between socioeconomic status and brand-name prescriptions

Generics/Research | Posted 31/07/2020

A link between socioeconomic status and the prescription of brand-name drugs in the US, has been revealed by a team of researchers based at Brown University [1].

Cost savings from the use of generic Gleevec (imatinib)

Generics/Research | Posted 17/07/2020

Modelling of the cost savings from the use of generic Gleevec (imatinib) in the US finds that US payers saved US$2.5 billion in years 1 and 2 following patent expiry. Projected savings in years 3 to 5 exceed US$12 billion, even without step-edit formulary management [1].

Cost-effectiveness of generic dabigatran

Generics/Research | Posted 10/07/2020

Since the enactment of Hatch-Waxman Act in 1984, use of generics has grown substantially in the US. Generics now account for nearly nine out of 10 prescriptions and are considered a cost-containment solution for escalating healthcare expenditures [1]. However, several factors may influence the use of generics including, but not limited to, the perception of the safety and effectiveness of these products [2]. The US Food and Drug Administration’s (FDA) standard of bioequivalence requires similar pharmacokinetic (PK) profiles of generic versus reference drug products with the assumption of similar pharmacodynamic (PD) effect. However, several instances related to generics substitution and treatment failures have led to concern particularly for drugs with narrow therapeutic indices and in therapeutic areas with severe effectiveness and safety outcomes.

Differences in originator and generic drug labels: impact on patient safety

Generics/Research | Posted 26/06/2020

The labels for established generics and their originators differ. Especially when it comes to safety messaging, these differences could have a fatal or life-threatening impact on patients, according to researchers from Switzerland [1].

Generics substitution in Finland: a pharmacy customer perspective

Generics/Research | Posted 19/06/2020

Generics offer less expensive alternatives to brand-name drugs. However, they must be accepted by patients to increase uptake and reduce healthcare cost. Finland adopted generics substitution in 2003. Then, in 2009, this was supplemented with a reference price system. A recent survey [1] has shown that the price of medicine is key for Finnish pharmacy customers.

US policy to combat high-priced generics

Generics/Research | Posted 29/05/2020

The cost of prescription drugs is a concern in the US. Drug prices typically decline once a generic drug is approved due to market competition. However, in recent years generics prices have risen and there have been shortages. The US Food and Drug Administration (FDA) has taken action to reduce prices and increase generics competition. It is hoped that this will increase access to medicines across the country.

Why does the US face high-priced generics and drug shortages?

Generics/Research | Posted 15/05/2020

Healthcare budgets in the US are under strain and the cost of prescription drugs is a continuous concern. Generic drugs offer cheaper alternatives to brand-name products due to competition. However, in recent years generics prices have risen in the US and there have been shortages of products.

Comparison of economic loss between generics and patented drugs in Indonesia

Generics/Research | Posted 17/04/2020

Poor management of the drug inventory in hospitals can be caused by stagnant and stock-out conditions, which might lead to economic loss. In order to investigate this phenomenon, researchers from Indonesia compared the economic loss between generics and patented drugs in stagnant and stock-out conditions at the Surabaya Islamic Hospital [1].

Generics outreach programmes should target high income groups

Generics/Research | Posted 27/03/2020

Patients with lower incomes are more likely to use generic drugs, finds a literature review from Auburn University, Alabama, USA [1].

Pharmacopeial standards may increase generics competition

Generics/Research | Posted 13/03/2020

Pharmacopeias, which contain descriptions of drug preparations, are critical for ensuring the safety of drug products. A study from Johns Hopkins University has now shown that pharmacopeial standards may also increase generics competition [1].

Delayed entry of buprenorphine generics cost NHS England GBP 0.5 million

Generics/Research | Posted 06/03/2020

A market analysis has shown that lack of competition for generic buprenorphinepatches meant the National Health Service (NHS) in England lost savings. The analysis estimates that if all generic drug products entered the market at the same time, the NHS could have saved GBP 0.5 million more over a six-month period [1].

Survey reveals attitudes to unauthorized hepatitis C generics

Generics/Research | Posted 28/02/2020

A survey of physicians, pharmacists, patients and other professionals in Switzerland has shown that, although most people think unauthorized generics are lower quality than their corresponding brand, they do support their import for those in need [1].

Medicare Part D has no impact on generics prescribing in long-term care

Generics/Research | Posted 17/01/2020

A recent observational study [1] in long-term care facilities in the US shows that the Medicare Part D programme has no significant effect on the rate of generic drug prescriptions, contrary to expectations.

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].