Generics/Research

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].

Free prescriptions do not always increase use of generics

Generics/Research | Posted 12/10/2018

One strategy to increase the use of generics is to offer them free of charge. This strategy presumes that this will shift demand away from expensive brand-name drugs and produce savings for insurers and customers alike. In order to test this theory, researchers from the University of Maryland studied co-payment data from Medicare recipients^# to see if offering zero generic co-pays for oral antidiabetic drugs (OADs) and statins increased generics use among low-income subsidy (LIS) patients with diabetes.

Limited distribution networks found to be anticompetitive

Generics/Research | Posted 05/10/2018

Limited distribution networks, whereby a drug manufacturer has a contract with one or a small number of distributors, suppress competition in both the generic and biosimilar drug markets. This leads to high costs for both payers and patients, according to a recent US review [1].

Generic hepatitis drug effective in patients with or without HIV

Generics/Research | Posted 28/09/2018

Over 3% of people with hepatitis C infections also have HIV. A new study conducted in Taiwan shows that generic versions of the hepatitis C treatment Epclusa are equally effective in patients with and without HIV co-infection [1].

Factors influencing the use of trade and generic names

Generics/Research | Posted 21/09/2018

Using trade names for drugs in clinical practice has been shown to increase the use of brand-name drugs. Despite efforts by academic medical centres to teach generic drug names and discourage the use of trade names to reduce bias and contain costs, usage of trade names persists. In order to determine what factors might influence healthcare professionals to prescribe by brand-name or generic name, researchers from Stanford University School of Medicine carried out an analysis of medication pages [1].

Hospital use of generic drugs increases adoption by community pharmacies

Generics/Research | Posted 14/09/2018

A recent Japanese study reveals that hospital adoption of generic drugs can also promote their use by community pharmacies. The researchers found that hospital adoption of generic drugs increased community pharmacy dispensation by almost 10% in only a year, reducing overall medical costs [1].

Product recalls increase with increasing generics competition

Generics/Research | Posted 24/08/2018

Generics price competition may lead to relaxed manufacturing standards and ultimately lower quality products, according to a study carried out by researchers from three US universities.

Patient sociodemographics and use of generics

Generics/Research | Posted 20/07/2018

Researchers from the US have found that poorer patients are more likely to use generics [1].

Generic sofosbuvir and daclatasvir bioequivalent to originators

Generics/Research | Posted 13/07/2018

With the aim of eliminating hepatitis C (HCV) by 2030, some originator pharmaceutical companies have granted voluntary licences to generics companies to mass produce the direct-acting antivirals (DAAs) sofosbuvir and daclatasvir at low cost. In order to achieve this, generics makers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originators. Therefore, researchers carried out a study to determine whether generics of sofosbuvir and daclatasvir had bioequivalent pharmacokinetics to the originators [1].