Generics

Health Canada clamps down on GMP compliance

Generics/General | Posted 20/03/2015

Canada’s federal health department Health Canada has written to its licensed drug and active pharmaceutical ingredients (API) manufacturers worldwide reminding them of their regulatory responsibilities and obligations. The department plans to step up planned and unplanned inspections of facilities, with the aim of taking timely and appropriate action where needed.

Ranbaxy fails to reverse FDA decision over Valcyte and Nexium

Generics/News | Posted 20/03/2015

Indian generics company Ranbaxy has yet again failed in its bid to become the first company in the US to sell generic versions of the AstraZeneca blockbuster acid-reflux drug Nexium (esomeprazole) and F. Hoffman-La Roche’s cytomegalovirus treatment Valycte (valganciclovir). Launching the first generic copies of the drugs would have given Ranbaxy six months of exclusivity on the market.

Potential savings of Euros 72 million with more generics use in three therapeutic areas

Generics/Research | Posted 13/03/2015

A nationwide cohort study in Austria reported that substituting branded medications with drugs containing the same active ingredients (generics) could save considerable amounts of money. A study at the Center for Medical Statistics, Informatics and Intelligent Systems (CeMSIIS) at the Medical University of Vienna, Austria, in cooperation with the Main Association of Austrian Social Security Institutions, has calculated the potential savings from generic medications used in the treatment of common conditions such as hypertension, hyperlipidaemia and diabetes mellitus. The potential annual financial savings for health insurance companies stand at around 18 per cent, equating to tens of millions of Euros [1].

Drug companies seek to block generic version of ulcerative colitis therapy

Generics/News | Posted 13/03/2015

The patent holder and manufacturer of Uceris (budesonide), a treatment for ulcerative colitis, have sued generics company Actavis for infringing their drug’s patents. Actavis recently filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Budesonide extended-release tablets, 9 mg.

Poor generics awareness among physicians in Saudi Arabia

Generics/Research | Posted 06/03/2015

A study looking at physicians’ knowledge, opinions and attitudes towards prescribing local generics in Saudi Arabia concludes that poor knowledge of local generics among consultant physicians working in government hospitals lies behind low prescription rates.

FDA cash to develop hard-to-copy generics

Generics/General | Posted 06/03/2015

The US Food and Drug Administration (FDA) is offering US$850,000 to research teams working on generics development. Funds will be split between three programmes: bioequivalence testing for long-acting periodontal drugs; developing methods for assessing long-acting injectable generics; and dissolution methods for long-acting levonorgestrel intrauterine system. Funds may be extended for a further two years.

US court invalidates asthma drug patent

Generics/News | Posted 06/03/2015

The US District Court of New Jersey ruled on 13 February 2015 that the patent protecting AstraZeneca’s inhaled asthma drug Pulmicort Respules (budesonide inhalation suspension) is invalid, opening the door to competition from generics.

Pfizer warns UK doctors not to prescribe generic Lyrica for pain

Generics/General | Posted 27/02/2015

Pharma giant Pfizer is fighting hard to protect one of its brand-name products, this time its epilepsy treatment Lyrica (pregabalin).

Actavis receives generic opioid approval and plans name change

Generics/News | Posted 27/02/2015

US generics maker Actavis announced on 20 February 2015 that it had received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for a generic version of Reckitt Benckiser’s Subutex (buprenorphine) sublingual tablets in dosages of 2 and 8 mg.

Substitution and adherence to antidiabetic generics in the elderly

Generics/Research | Posted 20/02/2015

When pharmacists switch from brand-name to generic drugs or between the same generics made by different manufacturers, this is thought may affect patient adherence to their medication. Therefore, Trotta and co-authors carried out a study to quantify the extent of switches between generic antidiabetics and to verify whether switching between different products of the same substance affects adherence [1].

Mylan being sued over sorafenib generic

Generics/News | Posted 20/02/2015

US-based Mylan is coming under fire from German pharma giant Bayer, as the generics maker is sued for violating patents on Bayer’s liver and kidney cancer drug Nexavar (sorafenib).

Dr Reddy’s could move manufacturing site with view to FDA approval

Generics/News | Posted 13/02/2015

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s), determined not to lose out on US Food and Drug Administration (FDA) approval for its generic version of the acid-reflux blockbuster Nexium (esomeprazole), is considering switching manufacturing to a new facility.

Generics versus brand-name drugs

Generics/Research | Posted 06/02/2015

Is there a benefit to prescribing brand-name drugs versus prescribing generics? The answer appears to be no, according to evidence collected by researchers from the University of British Columbia in Vancouver and the University of Alberta in Edmonton, Canada [1].

Akorn submits ANDA for difluprednate ophthalmic emulsion

Generics/News | Posted 06/02/2015

US generics maker Akorn has confirmed that it has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market difluprednate ophthalmic emulsion 0.05%.

Irish doctors’ attitudes towards generics

Generics/Research | Posted 30/01/2015

In June 2013, Ireland signed a new Act into law [the Health (Pricing and Supply of Medical Goods) Act 2013] paving the way for generics substitution and reference pricing for the first time in that market. As a consequence of the new legislation, Irish patients became more likely than ever to encounter generics.

FDA approves first generic esomeprazole

Generics/News | Posted 30/01/2015

Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. The drug is indicated to treat gastroesophageal reflux disease (GERD) in adults and children aged one year and older.

Generics applications under review by EMA – December 2014

Generics/General | Posted 23/01/2015

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].

Prasco to market authorized colchicine generic in the US

Generics/News | Posted 23/01/2015

US generics maker, Prasco Laboratories (Prasco), announced on 12 January 2015 that it had entered into an alliance with the US subsidiary of Japanese pharmaceutical company, Takeda, to distribute an authorized generic version of Colcrys (colchicine) in the US.

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.