Generics
FDA proposes standardization of generics standards
The US Food and Drug Administration (FDA) announced on 18 October 2018 that it has proposed to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to advance the harmonization of scientific and technical standards for generics.
China approves first ambrisentan generic
China’s drug regulator, the China Food and Drug Administration (CFDA, 国家食品药品监督管理局 in simplified Chinese), has approved its first ambrisentan generic.
Platelet reactivity with generic and brand-name clopidogrel
The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. However, there is a lack of information about inhibition of platelet reactivity by generic preparations. A study was therefore carried out using both generic and brand-name clopidogrel to compare the platelet reactivity [1].
Teva launches generic tadalafil but delays launch of generic Suboxone
Teva Pharmaceutical Industries (Teva) announced in September 2018 that it was launching generic tadalafil but would be delaying the launch of its higher-dose Suboxone (buprenorphine/naloxone) generic.
Free prescriptions do not always increase use of generics
One strategy to increase the use of generics is to offer them free of charge. This strategy presumes that this will shift demand away from expensive brand-name drugs and produce savings for insurers and customers alike. In order to test this theory, researchers from the University of Maryland studied co-payment data from Medicare recipients# to see if offering zero generic co-pays for oral antidiabetic drugs (OADs) and statins increased generics use among low-income subsidy (LIS) patients with diabetes.
European approval for fluticasone/salmeterol and gefitinib generics
Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 10 September 2018 that its subsidiary Glenmark Arzneimittel had secured marketing authorization in Germany for its generic fluticasone/salmeterol dry powder inhaler (DPI).
FDA approves first drug via Competitive Generic Therapy pathway
The US Food and Drug Administration (FDA) announced on 8 August 2018 that it had approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution.
Limited distribution networks found to be anticompetitive
Limited distribution networks, whereby a drug manufacturer has a contract with one or a small number of distributors, suppress competition in both the generic and biosimilar drug markets. This leads to high costs for both payers and patients, according to a recent US review [1].
Hospitals launch non-profit generics company
Several major hospital groups announced the official launch of their non-profit generics company, Civica Rx, on 6 September 2018. The company has been created in an effort to combat regular shortages and the increasing prices of drugs.
Generic hepatitis drug effective in patients with or without HIV
Over 3% of people with hepatitis C infections also have HIV. A new study conducted in Taiwan shows that generic versions of the hepatitis C treatment Epclusa are equally effective in patients with and without HIV co-infection [1].
