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.