Generics/Research

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.

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.

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