Generics
Out-of-pocket spending caps cut patient spending by a third
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].
EMA recommends approval for arsenic trioxide and fampridine generics
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting marketing authorization for two generic medicines: arsenic trioxide medac (arsenic trioxide) and Fampridine Accord (fampridine).
The benefits of tracking generic drug quality
Resources such as the US Food and Drug Administration’s (FDA) Sentinel Initiative should be used to their full potential in order to monitor the quality of generic drugs, suggests a recently published research letter [1].
Mylan launches first generic of Tecfidera in the US
On 19 August 2020, Mylan announced the launch of the first US Food and Drug Administration (FDA) approved generic of Biogen's multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate).
Evaluating reasons for US low generics substitution rates
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.
Lupin’s generic diabetes drug approved and asthma drug launched in US
In August 2020, India-based generics maker Lupin announced that it has received approval from the US health regulator to market a generic diabetes drug in America. Following previous US Food and Drug Administration (FDA) approval, it has also now launched generic tablets for the treatment of asthma in the US market.
Generics substitution in Finland: a pharmacy dispenser perspective
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].
Two additions to the South Korean generics market
In South Korea, a generic drug for the treatment of breast cancer and generic versions of Pfizer’s popular smoking cessation drug, Champix, are soon to become available. These additions to the South Korean market are likely to help it reach the US$20 billion that it is expected to reach in 2020 [1]. This recent leap in its pharmaceutical market size has been spurred on by significant government investments in generics and the fact that many originator drugs lose their patents in 2020, opening the market to generics.
Study reveals link between socioeconomic status and brand-name prescriptions
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].
Indian generics makers begin to dispatch remdesivir
Generic drugmakers Hetero and Cipla are among the first Indian manufacturers to dispatch a generic version of the investigational COVID-19 treatment remdesivir, which was originally developed by Gilead Sciences.