Generics

Extortionate increases in prices of 32 drugs a result of loophole in NHS pricing structure

Generics/General | Posted 05/08/2016

An investigation by The Times has exposed a small group of UK-based entrepreneurs to have profited vast amounts of money from hiking up the costs of 32 medicines for common conditions by GBP 262 million a year, a 12,500% increase.

Ways to reduce drug costs in Australia

Generics/Research | Posted 29/07/2016

Drug costs in Australia are increasing at an alarming rate. This is driven mainly by expensive biological therapies, antiviral therapies for HIV and hepatitis C and new cancer treatments.

AES position statement on substitution of generic anti-epileptics

Generics/Research | Posted 01/07/2016

A paper by the American Epilepsy Society (AES) discusses how the society’s position on generics substitution of anti-epileptic drugs has changed according to the results of bioequivalence studies [1].

Healthcare alliance proposes ways to reduce drug costs in the US

Generics/General | Posted 01/07/2016

Recent price increases in the US have prompted an alliance of doctors, pharmacists and health plan groups to release a document that outlines 12 policy proposals that it hopes will provide the framework for a major debate in Congress.

Reasons for the success of a generics company in the Sudan market

Generics/Research | Posted 24/06/2016

An exploratory, qualitative study carried out by colleagues from the University of Khartoum (Sudan) and Abertay University (UK) examined the reasons behind the success of a generics company that has been the market leader in Sudan for a decade from the perspective of employees and customers [1].

Glenmark gains approval for anti-epileptic generic

Generics/News | Posted 24/06/2016

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 19 May 2016 that it had received final approval from the US Food and Drug administration (FDA) for a generic version of Eisai’s epilepsy treatment Banzel (rufinamide).

Pharmacists prefer generic OTC medicines

Generics/Research | Posted 17/06/2016

In the US, the use of generics has been lacking due to hesitation from consumers over whether generics are as safe and effective as brand-name medications. Pharmacists, on the other hand, have the education and training to know that generics are both safe and effective.

China cuts prices for three drugs by more than 50%

Generics/General | Posted 17/06/2016

In an effort to lower spending on prescription drugs, China has cut the prices for three patent-protected drugs by more than 50%.

Dr Reddy’s to buy US generics from Teva

Generics/News | Posted 17/06/2016

Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) announced on 11 June 2016 that it had made a deal with Teva Pharmaceutical Industries (Teva) and an affiliate of Allergan to acquire a portfolio of eight abbreviated new drug applications (ANDAs) in the US.

Switching between generics of anti-epileptic drugs

Generics/Research | Posted 10/06/2016

Two different generic versions of anti-epilepsy medicine lamotrigine have been shown to be bioequivalent in patients with epilepsy and to not cause any differences in seizure frequency or adverse events, according to a study published in the February 2016 online edition of The Lancet Neurology.

Dr Reddy’s buys six OTC brands from Ducere Pharma

Generics/News | Posted 03/06/2016

Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) has entered the US branded consumer health products market by acquiring six over-the-counter (OTC) brands from US-based Ducere Pharma.

Cost-effectiveness analysis and incentivizing innovation

Generics/Research | Posted 27/05/2016

In the paper by Santiago Moreno and Joshua Ray, the controversial role that conventional cost-effectiveness analysis (CEA) plays in incentivizing innovation is revealed [1]. Detractors criticize its use for pricing purposes because it disregards the value of innovation brought by new drugs, while supporters argue that it is already accounted for. The objective of the paper is to identify the limitations of the conventional CEA approach and to propose an alternative that offers a more realistic estimate of the true value of innovation.

GSK appeals UK pay-for-delay fine

Generics/News | Posted 27/05/2016

GlaxoSmithKline (GSK) is appealing a GBP 37.6 million fine from the UK’s Competition and Markets Authority (CMA) over pay-for-delay allegations.

Perceptions of the value of generics in Brazil

Generics/Research | Posted 20/05/2016

Generics were first approved in Brazil in 1999. Substitution of generics and reference drugs can occur at the time of purchase and upon patients’ request, and, in the public healthcare system, physicians must prescribe drugs by their Brazilian Common Denomination (Denominação Comum Brasileira – DCB). However, despite legislation that supports their prescription, generics still have a small market share, representing only 27.3% of all drug units sold in Brazil in January 2014. A potential reason for the low penetration of generics into the Brazilian market is a negative perception of the value of generics.

Australian generics maker opens clinical trials facility

Generics/General | Posted 20/05/2016

IDT Australia announced on 2 May 2016 that it had opened a new clinical trials facility in Adelaide.

Perceptions of the substitution of generics

Generics/Research | Posted 13/05/2016

Pharmacists are mostly positive about the substitution of generics for brand-name drugs, according to a study analysing negative perceptions about generics, carried out by researchers from New Zealand and the US [1].

Generics applications under review by EMA – April 2016

Generics/General | Posted 13/05/2016

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 28 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].

FDA approves first generic rosuvastatin

Generics/News | Posted 13/05/2016

The US Food and Drug Administration (FDA) announced on 29 April 2016 that it had approved the country’s first generic version of Astra Zeneca’s leading cholesterol drug Crestor (rosuvastatin).