Generics
Generics applications under review by EMA – July 2020
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
Cost savings from the use of generic Gleevec (imatinib)
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
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.
Generics of apixaban and chlorzoxazone approved in EU and US
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a generic version of the anticoagulant medicine apixaban. Meanwhile in the US, the Food and Drug Administration (FDA) has approved a generic version of the muscle relaxant chlorzoxazone.
Differences in originator and generic drug labels: impact on patient safety
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 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.
HIV drug Kaletra appears on Russian black market
There are several reports of a black market in Russia emerging for the HIV drug Kaletra, following claims that it can be used to treat COVID-19.
Aurobindo Pharma receives FDA approval for three generics
India-based generics maker Aurobindo Pharma (Aurobindo) has received three approvals from the US Food and Drug Administration (FDA) in recent months, including for its generic versions of guaifenesin, fluoxetine and – via partner company Eugia Pharma – methotrexate.
US policy to combat high-priced generics
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.
COVID-19 drugs: Gilead’s remdesivir and Algernon’s alternative
Gilead Sciences has signed licensing agreements with five generics manufacturers based in India and Pakistan to increase production of its experimental COVID-19 drug remdesivir.
