Pharmacokinetics and generic drug switching: a regulators view

Genéricos/Investigación | Posted 13/11/2020

Researchers from the Netherlands share their view on the pharmacokinetic aspects of generic drug switching, from a regulatory perspective. They argue that there is no reason to change the current average bioequivalence-based approval pathway for generics [1].

Medicare Part D favours generics over brand-name drugs

Genéricos/Investigación | Posted 23/10/2020

A recent assessment of Medicare Part D [1] finds that insurance plans favour generic drugs over innovator products. Fewer than 1% of plans covered only the brand-name version of a drug in 2019.

Out-of-pocket spending caps cut patient spending by a third

Genéricos/Investigación | Posted 02/10/2020

Out-of-pocket spending caps on specialty drugs in the US have reduced spending by 32% for some patients, finds a new study of almost 30,000 specialty drug users [1].

Evaluating reasons for US low generics substitution rates

Genéricos/Investigación | Posted 11/09/2020

The uptake of generic drug products in the US has not met expectations despite their widespread availability and relatively low cost. A team of researchers based at Johns Hopkins University in the US, have now investigated the reasons for generics utilization and substitution across therapeutic classes. They reveal marked variation in reasons, with women less likely to substitute for generics, those using mail order pharmacies less likely to substitute, and state specific laws having little influence.

Generics substitution in Finland: a pharmacy dispenser perspective

Genéricos/Investigación | Posted 28/08/2020

In Finland, mandatory generic drug substitution was adopted in 2003 [1]. This is overseen by pharmaceutical staff who give advice to patients and decide which drug products they should receive. A recent study by Ranio et al. assessed the content of patient counselling about interchangeable medicines and generics substitution in Finnish community pharmacies [2].

Study reveals link between socioeconomic status and brand-name prescriptions

Genéricos/Investigación | Posted 31/07/2020

A link between socioeconomic status and the prescription of brand-name drugs in the US, has been revealed by a team of researchers based at Brown University [1].

Cost savings from the use of generic Gleevec (imatinib)

Genéricos/Investigación | Posted 17/07/2020

Modelling of the cost savings from the use of generic Gleevec (imatinib) in the US finds that US payers saved US$2.5 billion in years 1 and 2 following patent expiry. Projected savings in years 3 to 5 exceed US$12 billion, even without step-edit formulary management [1].

Cost-effectiveness of generic dabigatran

Genéricos/Investigación | Posted 10/07/2020

Since the enactment of Hatch-Waxman Act in 1984, use of generics has grown substantially in the US. Generics now account for nearly nine out of 10 prescriptions and are considered a cost-containment solution for escalating healthcare expenditures [1]. However, several factors may influence the use of generics including, but not limited to, the perception of the safety and effectiveness of these products [2]. The US Food and Drug Administration’s (FDA) standard of bioequivalence requires similar pharmacokinetic (PK) profiles of generic versus reference drug products with the assumption of similar pharmacodynamic (PD) effect. However, several instances related to generics substitution and treatment failures have led to concern particularly for drugs with narrow therapeutic indices and in therapeutic areas with severe effectiveness and safety outcomes.

Differences in originator and generic drug labels: impact on patient safety

Genéricos/Investigación | Posted 26/06/2020

The labels for established generics and their originators differ. Especially when it comes to safety messaging, these differences could have a fatal or life-threatening impact on patients, according to researchers from Switzerland [1].

Generics substitution in Finland: a pharmacy customer perspective

Genéricos/Investigación | 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.