Generics

Patient perceptions of generics in Ireland

Generics/Research | Posted 16/01/2015

In an attempt to benefit from the cost savings associated with use of generics, in June 2013 the Irish Government introduced generics substitution and reference pricing for the first time via the Health (Pricing and Supply of Medical Goods) Act. However, as perceptions of Irish patients towards generics have not been published previously, the objective of this study was to assess how generics were perceived amongst patients in the Irish health system [1].

US judge invalidates 4 of 5 patents on Cubicin

Generics/News | Posted 16/01/2015

A US federal judge has invalidated four out of the five patents on antibiotic Cubicin (daptomycin), paving the way for generics from June 2016.

GPhA comments on generics’ legislation and Trans-Pacific Partnership

Generics/General | Posted 09/01/2015

Mr Ralph G Neas, President and CEO of the US Generic Pharmaceutical Association (GPhA), has commented on proposed legislation for generics in the US, as well as on provisions in the Trans-Pacific Partnership that he believes could impede access to medicines.

Canada’s generics are too expensive

Generics/Research | Posted 12/12/2014

The same generics cost more in Canada than they do in similarly developed countries. In response to this, the premiers of each Canadian province recently agreed to lower the price of six expensive generics (amlodipine, atorvastatin, omeprazole, rabeprazole, ramipril and venlafaxine), setting reimbursement prices at 18% of the originator’s price. But this will still leave Canada out of line with other countries, including New Zealand, the UK and the US, say researchers at the University of Ottawa, Ontario, Canada.

EU Member States suspend generics approvals due to problems at CRO

Generics/General | Posted 12/12/2014

The European Medicines Agency (EMA) announced on 5 December 2014 that some Member States have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of studies conducted at India-based contract research organization (CRO) GVK Biosciences (GVK Bio) Hyderabad site.

First celecoxib generics hit US market

Generics/News | Posted 12/12/2014

On 10 December 2014, generics makers Actavis, Mylan and Teva Pharmaceutical Industries (Teva) announced that they had all launched celecoxib generics in the US.

Irish pharmacists’ perceptions and attitudes towards generics

Generics/Research | Posted 05/12/2014

In June 2013, new legislation came into effect in Ireland - the Health (Pricing and Supply of Medical Goods) Act 2013 - that introduced generics substitution and reference pricing for the first time in this market [1]. As a result of this new legislation, Irish patients have a greater likelihood of receiving a generic medicine in place of a brand-name prescription medication. As healthcare professionals’ perceptions of generics are likely to have an impact on the successful implementation of the objectives of this legislation, the aim of this study was to assess pharmacists’ opinions of, and attitudes towards, generics in Ireland [2].

Generics losing out to brand-name drugs in Croatia

Generics/Research | Posted 28/11/2014

A combination of weak national guidelines and powerful marketing by the pharmaceutical industry has led to a rise in brand-name over generics prescriptions for psychopharmaceuticals in Croatia.

FDA withdraws automatic substitution of two methylphenidate generics

Generics/News | Posted 28/11/2014

The US Food and Drug Administration (FDA) announced on 13 November 2014 that it had withdrawn the bioequivalence rating for two generic versions of Janssen Pharmaceutica’s attention deficit hyperactivity disorder drug Concerta (methylphenidate). The agency took the action due to concerns that the drugs may not be therapeutically equivalent to the brand-name drug.

Investigation into huge price increases for generics in the US

Generics/General | Posted 21/11/2014

Two US Congressmen have sent letters to 14 drug manufacturers, including several major Indian firms, requesting information about the escalating prices they have been charging for generics.

Cipla petitions Indian Government to revoke Onbrez patents

Generics/News | Posted 21/11/2014

India-based generics maker Cipla has asked the Indian Government to revoke five patents held by Swiss firm Novartis for its respiratory drug Onbrez (indacaterol), after launching its own generic version of the drug.

Canada partially lifts import ban on Indian manufacturing sites

Generics/General | Posted 14/11/2014

In an attempt to avert drug shortages, Canada’s federal department responsible for health, Health Canada, has partially lifted an import ban on products from three Indian manufacturing facilities that were banned from importing generics into the country due to quality violations.

FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs

Generics/News | Posted 14/11/2014

India-based generics maker Ranbaxy Laboratories (Ranbaxy) announced on 6 November 2014 that the company had been informed by the US Food and Drug Administration (FDA) of the agency’s decision to revoke its approval for the company’s generic versions of AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole) and F. Hoffman-La Roche’s cytomegalovirus treatment Valycte (valganciclovir).

Mylan latest to recall blood pressure generics

Generics/News | Posted 31/10/2014

US generics giant Mylan has become the latest in a line of generics companies that have faced recalls of the blood pressure medication metoprolol.

Changes to pharmaceutical policy during an economic recession

Generics/Research | Posted 24/10/2014

The use of antipsychotic medicines across Finland and Portugal following the recent economic recession have been analysed in order to gauge the impact of contrasting pharmaceutical policy interventions put in place over that time.

FDA names and shames firms for failing to pay generics fees

Generics/General | Posted 24/10/2014

No less than 28 generics makers are currently on the US Food and Drug Administration’s (FDA) GDUFA (Generic Drug User Fee Amendments) Facility Arrears List for failing to pay generics fees for 2013 and 2014.

Generics firms carve their way to victory

Generics/News | Posted 24/10/2014

US generics company Mylan has won a court battle over brand-name drugmaker Hospira, meaning it is now free to resume distribution of generic Precedex (dexmedetomidine injection).

Reference pricing and generics in Finland

Generics/Research | Posted 17/10/2014

Reference pricing and the extension of generics substitution have produced substantial savings in antipsychotic medication costs in Finland. The daily cost of treatment with clozapine, risperidone, olanzapine or quetiapine was cut by at least a third in just one year following the adoption of reference pricing for these drugs.