Generics

Generics applications under review by EMA – 2012 Q4

Generics/General | Posted 18/01/2013

Last update: 6 September 2013

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 EU member states and in Norway, Iceland and Liechtenstein. 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].

Patent cliff winners and losers

Generics/Research | Posted 11/01/2013

During 2011 and 2012 a whole host of patents have expired on many blockbuster drugs. In fact it was estimated that in 2012 US$33 billion of sales would be lost due to the patent cliff [1].

French Government pushing generics

Generics/General | Posted 11/01/2013

The French are in general mistrusting of generics with many choosing to stay with brand-name drugs. However, with rising healthcare costs and austerity measures hitting healthcare budgets, the French Government has had to introduce measures to increase generic drug use in the country.

US pharmacists positive about generic drugs

Generics/Research | Posted 14/12/2012

Pharmacists, prescribers and patients often voice concerns about the safety and efficacy of generic drugs when they are substituted for brand-name drugs. Results of a survey, reported by Ms Laurie Scudder, shows that pharmacist and prescriber opinions on generic drugs in the US are generally positive, see Figure 1.

Safety and efficacy of generic tenofir/lamivudine/efavirenz combination

Generics/Research | Posted 14/12/2012

New research shows the safety and efficacy of a generics combination of tenofir, lamivudine and efavirenz in the treatment of HIV-infected patients in Thailand [1].

Overview of research on ‘specific’ policies aimed at generics in 2012

Generics/Research | Posted 14/12/2012

Period: January to August 2012

Countries around the world have embraced generics due to their cost-saving potential. Many governments already have policies in place to promote the use of generic medicines, and as health systems face continuous cost pressures and demands to invest in new technologies, generics can only become more important.

Black-box safety warnings and the future of generic drug liability

Generics/Research | Posted 07/12/2012

Generic medicines currently have no responsibility for adding warnings about adverse effects of their medicines. Despite the US Supreme Court ruling that it was ‘impossible’ to force generics manufacturers to update their labels with the latest warnings, many feel that they have an ethical responsibility to do just that [1].

Ranbaxy not the only Indian generics maker subject to FDA recalls

Generics/News | Posted 07/12/2012

It seems that Ranbaxy Pharmaceuticals (Ranbaxy) is not the only Indian generics manufacturer who has been subjected to FDA recalls. It now comes to light that Dr Reddy’s Laboratories (Dr Reddy’s) and Aurobindo Pharma (Aurobindo) have also had to recall key generic drugs during 2012.

Overview of research on ‘general’ policies aimed at generics in 2012

Generics/Research | Posted 30/11/2012

Period: January to August 2012

Many governments around the world already have policies in place to promote the use of generic medicines, and with the increasing cost of health care and restrictions on budgets the need for low cost, quality medications can only become more important.

The ethics of generic drug liability

Generics/Research | Posted 30/11/2012

What responsibility should the manufacturers of generic medicines bear for warnings about adverse effects of their medicines? Indeed, what responsibility should be borne by the original manufacturers of these drugs? What happens if an adverse effect is noticed after the drug has been in use for many years? Such questions are being pondered in the US after a recent ruling in which the Supreme Court decided it was ‘impossible’ to force generics manufacturers to update their labels with the latest warnings.

India urged to drop cost-based drug policy

Generics/General | Posted 30/11/2012

Indian industry trade group the Associated Chambers of Commerce and Industry of India (ASSOCHAM) has urged the Indian Government to drop its cost-based price controls on both brand-name and generic drugs and instead introduce a market-based pricing policy.

Ranbaxy recalls generic atorvastatin in US

Generics/News | Posted 30/11/2012

Ranbaxy Pharmaceuticals (Ranbaxy) has fallen foul of FDA once again. The Indian generics major announced on its US website that it is conducting a voluntary recall for certain batches of its atorvastatin calcium tablets, a generic version of Pfizer’s blockbuster cholesterol-reducing drug Lipitor.

History and future of pay-for-delay

Generics/Research | Posted 23/11/2012

Pay-for-delay is a constant issue in both the US and Europe. But how did these settlements first come about and how have US courts attitudes towards such deals affected the pharmaceutical market [1].

Alleviating concerns around generic antiepileptic medications

Generics/Research | Posted 23/11/2012

Reports that some patients with epilepsy were more likely to experience seizures and hospitalisation after switching from brand-name drugs to generic alternatives have led to concerns about generic antiepilepsy drugs (AEDs). A recent review, however, argues that the onset of seizures following a switch may be due more to the disruption of normal routine than the choice of medication. The authors suggest that AEDs are relatively safe and effective compared to innovator drugs.

Generics competition for Pfizer’s sildenafil

Generics/News | Posted 23/11/2012

Apotex Corporation, Dr Reddy’s Laboratories, Mylan, Torrent Pharmaceuticals and Watson Laboratories have all received FDA approval for bioequivalent generic versions of Pfizer’s Revatio (sildenafil citrate – Viagra in Europe) in the US market following the approval by FDA of the generics companies abbreviated new drug applications (ANDAs) for sildenafil tablets.