Generics
Product recalls increase with increasing generics competition
Generics price competition may lead to relaxed manufacturing standards and ultimately lower quality products, according to a study carried out by researchers from three US universities.
Patient sociodemographics and use of generics
Researchers from the US have found that poorer patients are more likely to use generics [1].
MSF challenges hepatitis C patent in China
Médecins Sans Frontières (MSF, Doctors Without Borders) announced on 19 June 2018 that it was challenging the ‘unmerited’ patent in China for hepatitis C medicine velpatasvir from Gilead Sciences (Gilead). The health advocacy group said that ‘affordable generic versions from China could save millions of people’s lives’.
Generic cancer pain relief launched in Japan
Japan-based Daiichi Sankyo announced on 15 June 2018 that it had launched a generic version of cancer pain relief Fentos Tape (fentanyl citrate tape).
Generic sofosbuvir and daclatasvir bioequivalent to originators
With the aim of eliminating hepatitis C (HCV) by 2030, some originator pharmaceutical companies have granted voluntary licences to generics companies to mass produce the direct-acting antivirals (DAAs) sofosbuvir and daclatasvir at low cost. In order to achieve this, generics makers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originators. Therefore, researchers carried out a study to determine whether generics of sofosbuvir and daclatasvir had bioequivalent pharmacokinetics to the originators [1].
FDA approves first Suboxone generics for opioid dependence
The US Food and Drug Administration (FDA) announced on 14 June 2018 that it had approved the first generics of Suboxone (buprenorphine/naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. The generics have been developed by Indian generics maker Dr Reddy’s Laboratories (Dr Reddy’s) and US-based drugmaker Mylan.
UK investigates price increases for generics
In light of recent increases in the price of generics, the UK’s National Audit Office (NAO) has carried out an investigation into the causes of the increases.
Generic clopidogrel non-inferior to Plavix in acute coronary syndrome
A team of Canadian researchers have concluded that generic clopidogrel is non-inferior to the originator drug, Plavix (clopidogrel), in the treatment of patients with acute coronary syndrome [1]
FDA publishes list of companies that block generics
The US Food and Drug Administration (FDA) announced on 17 May 2018 that it had published a list of companies that block generics.
US approval for prostate cancer formulation and impotence generics
The US Food and Drug Administration (FDA) has approved generics of tadalafil, used to treat male impotence, and a new abiraterone formulation, a treatment for prostate cancer.
