Generics/Research

Cost savings after switching to generic tacrolimus

Generics/Research | Posted 04/12/2020

The use of narrow therapeutic index generic immunosuppressant in solid organ transplantation is controversial. This is because drugs with a narrow therapeutic index, such as immunosupressants, are defined by a narrow distance between the dosage that induces a desired effect and that dosage which already has a toxic effect [1]. This has led to medical and scientific societies being reluctant to switch to generics of these types of drugs because they think that small pharmacokinetic differences could predispose episodes of acute rejection or of adverse effects derived from toxicities of the product [2, 3].

Equivalent adherence with brand and generic osteoporosis treatments

Generics/Research | Posted 27/11/2020

Osteoporosis patients are just as likely to adhere to a generic bisphosphonate treatment as they are to a brand-name product, reveals a new study published in Scientific Reports [1].

Pharmacokinetics and generic drug switching: a regulators view

Generics/Research | 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

Generics/Research | 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

Generics/Research | 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

Generics/Research | 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

Generics/Research | 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

Generics/Research | 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)

Generics/Research | 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

Generics/Research | 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

Generics/Research | 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

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.

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.

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.

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].

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].

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].

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].

Medicare Part D has no impact on generics prescribing in long-term care

Generics/Research | Posted 17/01/2020

A recent observational study [1] in long-term care facilities in the US shows that the Medicare Part D programme has no significant effect on the rate of generic drug prescriptions, contrary to expectations.