Generics

Representatives object to 7-year biologicals exclusivity

In the ongoing debate about the exclusivity period for biologicals in the US, the latest group to voice their opinions are members of the US House of Representatives. In a letter to President Barack Obama, dated 14 October 2011, the 51 Representatives outlined their objections to the President’s continued efforts to reduce the exclusivity period for originator biologicals.

Pfizer settles with Teva but clashes with Watson over generics

Pfizer has gained a small reprieve from generic competition against its blockbuster cholesterol-reducing drug Lipitor, at least in the UK, by making a deal with Teva UK. However, the pharma giant has sued Watson Pharmaceuticals (Watson) to try and stop it selling its generic version of Embeda (morphine and naltrexone).

Industry adjustments as patents expire

Analysts are making some positive predictions as they consider the implications of the continued patent expiry of many blockbuster originator drugs.

Generics saved US$931 billion over last 10 years

On 21 September 2011, the US Generic Pharmaceutical Association (GPhA) released the results of an independent analysis showing that the use of generic drugs in the US has saved patients and the healthcare system US$931 billion between 2001 and 2010.

Teva takes over joint venture solidifying its position in Japan

Teva announced on 26 September 2011 that it will acquire the 50% interest formerly held by Kowa Company in Teva’s Japanese joint venture for US$150 million, giving it full control.

Actavis launches generic olanzapine in 11 European markets

Eli Lilly is facing yet more pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 30 September 2011, Actavis announced that it had launched generic olanzapine tablets in Austria, Denmark, Finland, France, Germany, Ireland, Italy, Romania, Sweden, The Netherlands and the UK, immediately after the patents on Zyprexa expired on 26 and 27 September.

Japanese government promoting generics

Japan is currently the world’s second largest pharmaceutical market, surpassed only by the US. The Japanese prescription drug market was valued at US$96 billion in 2010, however, only around 23% of its prescription drug sales (by volume) are generics [1].

Generic atorvastatin may be better than Crestor

AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin) failed to show a statistically significant benefit over Pfizer’s Lipitor (atorvastatin), according to results of a phase IIIb trial. The results could prove to be good news for generics manufacturers, boosting sales of generic atorvastatin, soon to compete with Crestor.

FDA blocks Indian API supplier

In a bid to get tough on foreign manufacturers, FDA has issued a warning letter and a US import ban to an Indian-based active pharmaceutical ingredient (API) manufacturer.

Debate over biosimilars exclusivity period in free trade agreement

With the eighth round of negotiations of the Trans-Pacific Partnership (TPP) agreement underway in Chicago, USA, on 12 September 2011 Democrat senators were split on the inclusion of intellectual property provisions that are consistent with US biologicals exclusivity standards, i.e. 12 years of data exclusivity.

Generics production pulled in different directions

A few months ago it was predicted that generics manufacturers were moving ahead with the development and commercialisation of better manufacturing technologies. The largest firms had now developed to the point at which they can start to develop new manufacturing technologies and thus lower their costs. This was going to lead, on the one hand, to lower prices for products and at the same time, higher profits for those firms able to develop in this way, who were then going to further consolidate their market position.

Tendering for medicines in ambulatory care

Tendering is a mechanism whereby a purchaser buys medicines from the pharmaceutical manufacturer that offers the best bid [1]. Whereas tendering is widely used in the hospital sector, it is only recently being rolled out in ambulatory care in an increasing number of countries with a view to constraining pharmaceutical expenditure. Denmark, Germany and The Netherlands are the countries that have taken up the idea most readily. However, the success of this strategy is not yet clear compared to other European generic medicines pricing policies.

Ranbaxy to launch generic atorvastatin on time

Ranbaxy Laboratories will release a generic version of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) in the US at the end of November 2011 as planned, according to a report in the Japanese newspaper Nikkei.

US drug shortages prompt oncologists to go into drug manufacture

Drug shortages in the US are at a record high and there appears to be no quick solution to the problem. Legislation, government stock-piling and physicians importing or even manufacturing drugs are just some of the solutions being proposed.

Sanofi France to make generic atorvastatin

The French daily newspaper, Les Echos, reported on 1 September 2011 that sanofi France (sanofi) had reached an agreement with Pfizer to produce generic versions of the blockbuster cholesterol drug Lipitor (atorvastatin).

Ranbaxy launches generic esomeprazole in the UK

India-based Ranbaxy Laboratories announced on 5 September 2011 that it had successfully launched esomeprazole magnesium 20 mg and 40 mg tablets in the UK.

Teva continues its fight to prevent generic glatiramer acetate

Teva Pharmaceutical Industries (Teva) has not given up the fight to keep generics competition away from its blockbuster drug, Copaxone (glatiramer acetate). The company announced on 29 August 2011 that a US federal court had rejected interpretation claims from its challengers in patent infringement lawsuits over its proprietary multiple sclerosis treatment, setting a trial date of 7 September 2011.

New Spanish prescribing laws to promote generics

In an attempt to reduce the healthcare bill the Spanish government has approved new rules to force Spanish doctors to prescribe and pharmacies to dispense generic drugs rather than more expensive brand-named medicines.

Ranbaxy may sell its generic atorvastatin exclusivity

According to Credit Suisse analysts, Ranbaxy Laboratories (Ranbaxy) may sell its rights to make a generic version of Pfizer’s cholesterol blockbuster Lipitor (atorvastatin), should it look unlikely to gain FDA approval in time for the planned November 2011 launch.

Generics manufacturers do not have to change drug safety labels in the US

A landmark ruling from the US Supreme Court has decided that generic drug manufacturers do not have to change their drug’s safety label, even if stronger safety warnings are found to be required [1- 2]. This is the opposite of a ruling in 2009 that decided that patients could sue the manufacturer of a brand-name drug if its safety label is found to be inadequate, e.g. when new drug-related risks are discovered after the drug has made it to market [3, 4].

Integrated prescriber dispensing can slow generic growth

Countries such as China, Japan and Taiwan which have public health insurance systems, and which allow physicians to both prescribe and dispense drugs themselves, are the most resistant to generics competition, according to a study by two Taiwanese health economists from the National Cheng-Kung University and Academia Sinica, Taipei, Taiwan [1].

Does switching to generic anti-epileptic drugs lead to loss of seizure control

Patients with epilepsy may have a higher risk of seizures if they switch from their brand-name medication to generic anti-epileptic drugs (AEDs). This is the message often heard from clinicians when expressing their concern over generic versions of narrow therapeutic index (NTI) drugs, one class of which is those used to manage the symptoms of epilepsy.

Pfizer seeks 6-month paediatric exclusivity for Lipitor

Pfizer is poised for a Lipitor (atorvastatin) reprieve in Europe. The company has asked for six months of additional exclusivity in most EU countries under regulations designed to promote drug trials for children. The extension could be worth almost US$800 million as it staves off generic competition until May 2012.

Pilot programmes between EMA, FDA and TGA a success

Two pilot programmes of collaboration on inspections between EMA, FDA and the Australian Therapeutic Goods Administration (TGA) have concluded successfully, according to two reports published by the EMA on 2 August 2011. The two programmes were carried out with the intention of increasing international regulatory collaboration in order to increase drug quality and safety.

Switching from a brand-name antiepileptic drug to a generic is not associated with a higher risk of seizures

A report in Clinical Pharmacology and Therapeutics provides further evidence that patients with epilepsy do not have a higher risk of seizures if they switch from their brand-name anti-epileptic drugs (AEDs) to the generic version [1].

How successful is the reference pricing system in Belgium

The main aim of a reference pricing system (RPS) is to provide generic medicines at the lowest cost to the state and individuals. This article explains how RPSs work and asks how the Belgian system might be improved to better fulfil its main objective.

GPs in the UK to be banned from prescribing branded statins

General Practitioners (GPs) in Cambridgeshire, UK, have been told by the national health service (NHS) that they are considering proposals to ban prescribing of branded statins in favour of cheaper generic alternatives according to a report in Pulse.

Benefits of generics called into question

The benefits associated with generic prescription drugs have been called into question in an article published in the British Medical Journal (BMJ) [1].

UK Government sues Servier for generic blocking

The UK’s Health Secretary, Mr Andrew Lansley, has issued a GBP 220 million (Euros 246 million; US$360 million) lawsuit against French drug company Servier for allegedly ‘abusing’ its dominant position and delaying rivals from launching generic versions of its angiotensin-converting enzyme inhibitor, perindopril (Coversyl).

Epilepsy: medical concerns of prescribing generics

Generic economics

Generic medications are generally cheaper than their branded product counterparts and so prescribing these is encouraged as a cost-containment strategy in the management of healthcare resources. Encouraging the use of generic drugs is widely considered to be the most simple and effective way of reducing medication expenditure.

Factors that influence generic drug use

Increasing efforts to influence both the prescriber and patient factors involved in determining the type of initial prescription may benefit everyone involved in paying for medications to get the most cost-effective treatment for their condition.

Market share of generics set to rise as blockbuster patents end

Sales of generic drugs across Europe are expected to grow by 63% in the next three years, mainly because the patents of nine major blockbuster drugs are due to run out [1].

Influence these two factors and the use of generics will increase

According to Assistant Professor William Shrank of Harvard Medical School, Boston, USA, we may be able to increase the use of generic alternatives over brand-name medications if we influence the following two factors: communication about generics between patients and their physicians or pharmacists and the patients’ comfort with generic substitution.

Domestic Indian market spawns generic agreements

India’s population is growing rapidly—as is its economy—creating a large middle class with the resources to afford western medicines. This fact has seen a spate of western companies stepping forward to make agreements with Indian generics manufacturers in order to get a foothold in this developing market.

TRIPS and access to essential medicines

A large number of people in the world cannot afford the basic necessities of life, which include access to essential medicines. Policies to encourage generic medicines in poorer countries may go some way to making essential medicines available for all, however, global intellectual property agreements may hinder these efforts.

US drug shortages – FDA may hinder, but APP may help

Drug shortages are at a record high, and some blame the policies of the FDA for causing some of these. However, good news is on the horizon as US drugmaker APP Pharmaceuticals has decided to boost its manufacturing capacity for injectable generic drugs. This could help to fight against the growing list of drug shortages reported by the FDA.