Generics

Generics applications under review by EMA – 2012 Q4

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

FDA grant to study generic versus brand-name transplant drugs

FDA has given a grant to the University of Cincinnati, Ohio, USA, in order to support a study into a commonly used immunosuppressive drug for transplant patients, tacrolimus.

German court rules Seroquel XR patent invalid

AstraZeneca has lost another battle to protect its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate) against generics.

EMA approves first generic imatinib

EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2012 that the agency had approved a generic version of imatinib.

Overview of clinical research on generics in 2012

Period: January to August 2012 

Generic drug alternatives to brand-name prescription medications are becoming increasingly important in the global drug market as governments strive to contain healthcare costs and as an increasing number of prescription drugs lose patent protection.

FDA ordered to let Watson sell generic Actos

Watson Pharmaceuticals (Watson) has finally won its legal battle to be able to sell a generic version of Takeda Pharmaceutical’s diabetes drug Actos (pioglitazone hydrochloride). A US judge ordered FDA to approve Watson’s generic pioglitazone against the agency’s decision to bar Watson during the first six months of generics availability.

Momenta versus Amphastar and the safe harbour provision

On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1) covers post-approval testing as long as it is ‘reasonably related’ to the submission of information to FDA. The case involved was that of Momenta Pharmaceuticals (Momenta) versus Amphastar Pharmaceuticals (Amphastar) (Federal Circuit No. 2012-1062, 8/3/12).

Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity

US-based Mylan has sued FDA for refusing to grant approval to sell a generic version of Novartis’s heart treatment, Diovan HCT (valsartan/hydrochlorothiazide), ‘after a competitor failed to get the drug on the market in time’.

Teva withdraws generic antidepressant from US

Israel-based Teva Pharmaceutical Industries (Teva), the world’s largest generics manufacturer, has removed its Budeprion XL 300 mg generic version of GlaxoSmithKline’s antidepressant Wellbutrin XL (bupropion) from the US market after regulators said it is not therapeutically equivalent to Wellbutrin XL 300 mg.

FDA gives generics greater importance

The Office of Generic Drugs has been promoted to the highest position within FDA because of the great amount of work and income/expenditure now associated with generics.

Mylan debuts first generic Diovan HCT and Antivert in USA

Mylan is first off the mark once again with its latest generics launch. Mylan announced on 21 September 2012 that its subsidiary Mylan Pharmaceuticals has received final approval from FDA for its Abbreviated New Drug Application (ANDA) for valsartan/hydrochlorothiazide tablets USP.

Generics applications under review by EMA

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].

Bayer loses Nexavar compulsory licence appeal

Bayer has lost its appeal to the Indian Government’s decision to grant a compulsory licence for its cancer drug Nexavar (sorafenib).

Suggestions for increasing generics use in Abu Dhabi

This concluding article in a series of three suggests ways of improving the use of generics in Abu Dhabi.

Use of generics in Abu Dhabi

The second of three articles examining how to increase generics use in Abu Dhabi.

Canada takes another step towards generics

For the first time, two of Canada’s biggest health insurance companies are going to require that generics be prescribed if one is available.

Hospira acquires manufacturing, R & D facilities in India

On 29 August 2012, US-based Hospira announced an agreement to acquire an API (active pharmaceutical ingredient) manufacturing facility, together with an associated research and development (R & D) facility, from Orchid Chemicals & Pharmaceuticals. The modern, FDA-approved facility is costing approximately US$200 million. Acquisition of this leading Indian pharmaceuticals company is expected to reduce Hospira’s costs, support continuity of supply of key antibiotic products and pave the way for future API development [1].

Maximising the potential of generics in Abu Dhabi

Introduction
All residents in Abu Dhabi have access to health care via mandatory health insurance. Nationals, who comprise 20% of the population with two-thirds under 30 years of age and half under 19 years of age, have automatic access to comprehensive health care funded by the government. In 2008, all nationals received cards giving free access to health care and choice of provider in both the public and private sectors [1].

Mylan generics launches in the US

Mylan has 166 abbreviated new drug applications (ANDAs) pending Food and Drug Administration approval representing US$78.4 (Euros 61.3) billion in annual sales. Thirty-five of these are potential first-to-file opportunities, representing US$25.1 (Euros 19.6) billion in annual brand sales (2011 IMS Health figures).

Poor quality pharma ingredients abound in China

Lack of regulatory enforcement in China is allowing poor quality pharmaceutical ingredients to be sold to drug manufacturers with potentially dangerous or even fatal consequences for patients.

Impax settles patent dispute with Genzyme

Impax Laboratories (Impax) announced on 4 September 2012 that it had reached an agreement with Sanofi subsidiary, Genzyme Corporation (Genzyme), to settle pending US litigation with regard to the production and sale of generic versions of Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride).

Austria could save Euros 256 million by using more generics

A recent study by IMS Health Austria (IMS) revealed that in Austria healthcare payers could have saved more than a quarter billion Euros during 2011 if physicians would have prescribed more generics to their patients.