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News

EMA recommends approval for arsenic trioxide and fampridine generics posted 25/09/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it...

Mylan launches first generic of Tecfidera in the US posted 15/09/2020

On 19 August 2020, Mylan announced the launch of the first US Food and Drug Administration (FDA) approved generic of Biogen's...

Lupin’s generic diabetes drug approved and asthma drug launched in US posted 06/09/2020

In August 2020, India-based generics maker Lupin announced that it has received approval from the US health regulator to mark...

Two additions to the South Korean generics market posted 28/08/2020

In South Korea, a generic drug for the treatment of breast cancer and generic versions of Pfizer’s popular smoking cessation...

Indian generics makers begin to dispatch remdesivir posted 24/07/2020

Generic drugmakers Hetero and Cipla are among the first Indian manufacturers to dispatch a generic version of the investigati...

 

Research

Evaluating reasons for US low generics substitution rates posted 16/09/2020

The uptake of generic drug products in the US has not met expectations despite their widespread availability and relatively l...

Generics substitution in Finland: a pharmacy dispenser perspective posted 03/09/2020

In Finland, mandatory generic drug substitution was adopted in 2003 [1]. This is overseen by pharmaceutical staff who give ad...

Study reveals link between socioeconomic status and brand-name prescriptions posted 01/08/2020

A link between socioeconomic status and the prescription of brand-name drugs in the US, has been revealed by a team of resear...

Cost savings from the use of generic Gleevec (imatinib) posted 22/07/2020

Modelling of the cost savings from the use of generic Gleevec (imatinib) in the US finds that US payers saved US$2.5 billion...

Cost-effectiveness of generic dabigatran posted 16/07/2020

Since the enactment of Hatch-Waxman Act in 1984, use of generics has grown substantially in the US. Generics now account for...

 

General

The benefits of tracking generic drug quality posted 23/09/2020

Resources such as the US Food and Drug Administration’s (FDA) Sentinel Initiative should be used to their full potential in o...

Generics applications under review by EMA – July 2020 posted 22/07/2020

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the lo...

HIV drug Kaletra appears on Russian black market posted 22/07/2020

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

CMS proposes new measures to rate generic usage posted 22/07/2020

The Centers for Medicare & Medicaid Services (CMS) is actively working to promote competition and lower costs for drugs,...

Science, outreach, development: US Generics Drugs Office reaches new highs in 2019 posted 22/07/2020

The US Food and Drug Administration (FDA) Office of Generic Drugs 2019 Annual report gave updates on the number of generics a...