Generics

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.

HIV drug Kaletra appears on Russian black market

Generics/General | Posted 12/06/2020

There are several reports of a black market in Russia emerging for the HIV drug Kaletra, following claims that it can be used to treat COVID-19.

Aurobindo Pharma receives FDA approval for three generics

Generics/News | Posted 12/06/2020

India-based generics maker Aurobindo Pharma (Aurobindo) has received three approvals from the US Food and Drug Administration (FDA) in recent months, including for its generic versions of guaifenesin, fluoxetine and – via partner company Eugia Pharma – methotrexate.

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.

COVID-19 drugs: Gilead’s remdesivir and Algernon’s alternative

Generics/News | Posted 22/05/2020

Gilead Sciences has signed licensing agreements with five generics manufacturers based in India and Pakistan to increase production of its experimental COVID-19 drug remdesivir.

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.

FDA approves Proventil and Daraprim generics

Generics/News | Posted 08/05/2020

The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal.

CMS proposes new measures to rate generic usage

Generics/General | Posted 04/05/2020

The Centers for Medicare & Medicaid Services (CMS) is actively working to promote competition and lower costs for drugs, according to a statement released in February 2020, which also details new measures of generics usage to help calculate a plan’s star rating.

Science, outreach, development: US Generics Drugs Office reaches new highs in 2019

Generics/General | Posted 24/04/2020

The US Food and Drug Administration (FDA) Office of Generic Drugs 2019 Annual report gave updates on the number of generics approvals in 2019. These remained high at 1,014 [1-3]. The report also discussed the progress of the FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme [4], and information about the achievements of the Office of Generic Drugs (OGD) in terms of research proposals, outreach activities and international development.

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].

Improving the pathway for generics approval in the US: 2019 update

Generics/General | Posted 17/04/2020

The US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 annual report in February 2020. This gave updates on the number of generics approvals in 2019 which reached 1,014. It also gave information on the progress of FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme in 2019.

Generics approvals remain high in US in 2019

Generics/General | Posted 10/04/2020

In February 2020, the US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 Annual report which highlighted the year’s key achievements. The report stated that in 2019, the Office of Generic Drugs (OGD) facilitated 1,014 generic drug final and tentative approvals. This is slightly lower than the 1,021 approvals of 2018 but remains high enough to make a positive contribution to the FDA’s generic drug programme.

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].

FDA approves lung cancer and anticoagulant generics

Generics/News | Posted 20/03/2020

The US Food and Drug Administration (FDA) has issued a final approval for a generic version of Alimta (pemetrexed) and two new generics of Eliquis (apixaban).

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].

Chinese company makes copy of patented coronavirus treatment remdesivir

Generics/News | Posted 28/02/2020

China’s BrightGene has successfully produced remdesivir, an experimental treatment for coronavirus, however, patents for the drug are currently held by the American company Gilead.

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].