Generics

MSF challenges hepatitis C patent in China

Generics/General | Posted 20/07/2018

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

Generics/News | Posted 20/07/2018

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

Generics/Research | Posted 13/07/2018

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

Generics/News | Posted 13/07/2018

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

Generics/General | Posted 06/07/2018

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

Generics/Research | Posted 29/06/2018

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

Generics/General | Posted 22/06/2018

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

Generics/News | Posted 22/06/2018

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.

Doctors’ perceptions of generics in Guadeloupe and Martinique

Generics/Research | Posted 15/06/2018

Doctors in Guadeloupe and Martinique are not hostile towards generics but still mostly prescribe brand-name drugs due to patient preferences, according to a study analysing the perceptions of doctors towards generics in the French speaking territories [1].

Aurobindo and Lannett expand their generics portfolios

Generics/News | Posted 15/06/2018

Both Indian generics maker Aurobindo Pharma (Aurobindo) and US generics company Lannett have announced efforts to increase their generics portfolios.

Generics market failures and non-profit manufacturing

Generics/Research | Posted 08/06/2018

Competition usually keeps the price of generics well below that of brand-name drugs. However, when there is little or no competition, generics makers can substantially increase prices, which may lead to drug shortages. One way to address such market failures could be to introduce a non-profit generics maker to the market, according to researchers from Intermountain Healthcare, the Johns Hopkins Carey Business School and the Johns Hopkins Bloomberg School of Public Health [1].

FDA to boost generics and change drug rebates to lower prices

Generics/General | Posted 08/06/2018

In two recent speeches US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has outlined plans to fight back against high drug prices. Two of the ways the agency plans to do this include increasing generics and targeting drug rebates

Antitrust activities in the pharmaceutical industry

Generics/Research | Posted 01/06/2018

High prices of prescription drugs have been highlighted as reducing access to essential drugs and have recently gained notoriety and political attention. Authors from Harvard Medical School and the law schools of the Northeastern and Rutgers Universities explain the role of antitrust law in restoring competition and restraining price increases [1].

China to exempt cancer drugs from import taxes

Generics/General | Posted 01/06/2018

Under a new policy that took effect on 1 May 2018, China will exempt as many as 28 medicines, including all cancer drugs, made overseas from import duties.

Encouraging generics could cause high prices

Generics/Research | Posted 25/05/2018

A provision introduced in October 2017 awards eligible drugmakers 180 days of exclusivity to market a generic version of one of a list of 267 medicines for which no generic version currently exists. The provision was introduced to encourage generics of off-patent drugs without generics, however, some believe it could lead to high prices [1].