Generics
Pfizer continues to fight for Lipitor
With the patent expiry of Pfizer’s blockbuster cholesterol-reducing drug Lipitor (atorvastatin) on 30 November 2011, Pfizer it seems is pulling out all the stops to delay generic erosion of its market share.
Ranbaxy may settle with FDA for generic atorvastatin launch
According to The Times of India, generics giant Ranbaxy Laboratories and FDA are getting closer to reaching an agreement to solve the Indian drugmaker’s regulatory troubles.
Quality by design for generics by 2013
Quality by design (QbD) is already being implemented by FDA for new drug applications, but now, in an attempt to prepare generics manufacturers for QbD in 2013, FDA is preparing to publish immediate and modified release QbD examples.
The pharmaceutical market in Brazil
The Brazilian pharmaceutical market is the third largest in the Americas region, after Canada and USA, it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income, therefore, the market outlook is positive for the 2011–2016 period.
Advocates demand generic version of Abbott’s HIV drug Kaletra
FDA watchdog Public Citizen, along with public health groups in a dozen countries, has launched a global campaign demanding the authorisation of generics competition for Abbott Laboratories’ HIV drug Kaletra (lopinavir/ritonavir) before its exclusivity expires.
Ranbaxy gets FDA approval and launches generic atorvastatin
After all the speculation India-based Ranbaxy Laboratories (Ranbaxy) has resolved all outstanding issues and finally managed to gain approval from FDA for its generic version of the blockbuster cholesterol-reducing drug Lipitor (atorvastatin).
Strides Arcolab gains FDA approval for two cancer generics
India-based generics manufacturer Strides Arcolab announced on 24 November 2011 that its wholly-owned subsidiary, Onco Therapies, had gained FDA approval for generic versions of cancer treatments carboplatin and oxaliplatin.
Mylan poised to enter generic inhalers market
The global market for respiratory asthma and chronic obstructive pulmonary disorder (COPD) inhalers, a specialist field, is valued at more than US$34 billion (Euros 25.1 billion) and is averaging 7% growth per year according to IMS Health. More than 50% of this market is expected to lose patent protection by the end of 2016, including several blockbuster products, many of which are inhaler based.
Actavis launches generic valsartan in Europe
On 18 November 2011, Iceland-based generics company Actavis announced the launch of generic valsartan and valsartan HCT in nine European countries.
Generic atorvastatin partnership
In early November 2011, there has been speculation that Ranbaxy Laboratories and Teva are about to join in manufacturing generic atorvastatin, better known as Lipitor, in the US.
Stada to buy Spirig’s generics business
German generics giant Stada Arzneimittel announced on 9 November 2011 that it had signed a deal to buy Switzerland-based Spirig Pharma’s generics business for approximately Euros 78 million.
AstraZeneca settles patent dispute over Seroquel XR
In an out-of-court deal, AstraZeneca has agreed with Accord Healthcare, Handa Pharmaceuticals and Intas Pharmaceuticals that the latter can sell generic forms of the antipsychotic blockbuster Seroquel XR (quetiapine fumarate) from 1 November 2016.
Translational research to uncover new uses for generics
On the surface, generic compounds and translational medicines could not appear more different. However, in April 2011, the US National Institutes of Health (NIH) met with academic, governmental, and industry R & D experts to discuss whether translational methods could help to rescue and re-position certain generics [1].
Generic olanzapine now approved in US
Eli Lilly has no safe haven left as the FDA announced on 24 October 2011 that it had approved the first generic olanzapine (for treating schizophrenia and bipolar disorder) drugs, one day after the company lost its patent protection on Zyprexa (olanzapine) in the US on 23 October 2011 [1].
South Africa-India alliances for generics and drug delivery systems
South Africa-based Litha Healthcare Group signed an exclusive agreement with Indian generic drugmaker Natco Pharma (Natco) on 19 September 2011. Under the group’s newly formed generics business unit, the agreement will include a range of generic pharmaceutical products developed and manufactured by Natco.
Row continues over drug shortages
Unhappiness about persistent drug shortages is becoming more acute, both in Europe and the US. Hospitals in The Netherlands are routinely short of around 40 products, whereas in the US 180 medications have now made it onto FDA’s list of scarce products. Hospital pharmacists spend an increasingly large amount of time trying to source scarce items and, despite their best efforts, doctors and patients are increasingly noticing the scarcities.
Access to generic medicines undermined in free trade agreement
On 19 October 2011, several leading Congressional Democrats wrote a letter to the US Trade Representative urging him to ensure that access to generic medicines in the developing world is not undermined during negotiations for the Trans-Pacific Partnership (TPP), currently being carried out in Peru between the US and the Asia-Pacific region.
European Commission investigates Johnson & Johnson and Novartis over delaying generics
As part of its ongoing antitrust investigations, the European Commission (EC) announced on 21 October 2011 that it is looking into agreements between Johnson & Johnson (J&J) and Novartis to determine whether they delayed the entry of a generic version of the fentanyl painkiller in The Netherlands. If the drugmakers had ‘contractual arrangements’ that hindered a generic drug, this would ‘potentially’ breach EU antitrust rules.
Injectable generics at Strides Arcolab
India-based drug firm Strides Arcolab announced on 3 October 2011 that it had received FDA approval to market injectable clindamycin, used in the treatment of bacterial infections, in the American market.
Another olanzapine generic hits the market
The competition is hotting up for Eli Lilly as yet another generics maker joins the list of those already producing copies of its blockbuster antipsychotic drug Zyprexa (olanzapine).
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.
Generics will not have to change their labelling
The US Supreme Court has decided that generics makers cannot be sued under state law for not changing their labels to warn of possible side effects. That is a big victory for Actavis, Mylan and Teva, which had faced appeals against court rulings that would have allowed them to be sued under state law.
The ‘Wise List’ - a Swedish drug formulary
Research carried out by Lars Gustafsson and et al. [1] into the use and acceptance of a drug formulary used in Stockholm, Sweden, found that adherence to the ‘Wise List’ resulted in substantial cost savings due to increased use of cheaper generic drugs.
Savings to be made and compliance with generic antidepressants
Vlahiotis A et al. compared discontinuation rates and healthcare utilisation costs among patients using brand-name versus generic antidepressants.
No difference between generic and brand-name antidepressants
Patients who start treatment for depression with generic drugs benefit from significantly lower costs and are just as likely to keep taking their medication as those who start on brand-name medicines new research suggests.
Pfizer in joint venture with Chinese generics maker Hisun
US pharma giant Pfizer announced on 2 June 2011 that it had signed a memorandum of understanding (MOU) with Chinese generics manufacturer Zhejiang Hisun Pharmaceuticals (Hisun) on their intention to establish a joint venture. This potential partnership would aim to strengthen the ability of both companies to reach more patients with high-quality and low-cost medicines in the branded generics arena.
Compliance with generic drug use among Pakistani immigrants
Patients using antihypertensives, antidiabetics or cholesterol-lowering drugs were interviewed using a questionnaire in the study which investigated the perceptions of generic substitution among Pakistani immigrants in Oslo, Norway, and how this affected compliance with their long-term drug use and may be affected by confusion of generic drugs with counterfeit drugs [1].
Different routes for generics and brand-name drugs
Comparison of the route to market generics and brand-name drugs was discussed by Dr Lewek and Dr Kardas in their recent research paper on the benefits and risks of generic substitution.
Perception of generic drugs as fake among Pakistani immigrants
Pakistani immigrants in Norway may confuse generic drugs with counterfeit drugs, according to research carried out by Norwegian researchers [1].
The benefits of generic substitution
Recent research carried out by Drs Lewek and Kardas, showed that generic drugs are equally as safe and effective as their brand-name equivalents. Patient compliance and cost were also found to be better with generics compared to brand-name drugs.
Generic warfarin as safe and effective as brand name
In a literature study by Dr Francesco Dentali and colleagues found that generic warfarin was as safe as brand name warfarin (Coumadin) [1].
Pakistani immigrants may confuse generics with counterfeit drugs
A study by Norwegian researchers showed that generics substitution may lead to lack of compliance in Pakistani immigrants in Norway, due to misconceptions and confusion with counterfeit drugs [1].
Benefits and risks of generic substitution
According to the FDA, each year, Americans save an estimated US$8–10 billion by purchasing generic drugs rather than branded medications. These savings are, of course, the key advantage of generics. However, the very reason for these cost savings—the fact that generic drugs do not have to undergo the large, expensive clinical trials that are required for approval of branded drugs—gives rise to questions about the quality and safety of generics.
Europe’s industry concerned about converging prices and patient access
In response to a report on reference pricing in the EU, the European Federation of the Pharmaceutical Industries and Associations (EFPIA) says that while ‘it is rational for a Member State without resources to assess the value [of a medicine] to refer to a similar country that does … it is not appropriate for higher-income countries to mechanistically refer to prices in countries with a much lower purchasing power’.
Generic substitution generates savings in South Africa
Savings of 9.3% over the 3-year study period could have been made with generic substitution of antidepressants according to research carried out by the School of Pharmacy at the North-West University, South Africa.
Mylan’s attempt to stop Ranbaxy’s Lipitor exclusivity fails
On 2 May 2011 a federal judge dismissed Mylan’s attempt to block rival generic company Ranbaxy Laboratories from launching a generic version of Pfizer’s blockbuster cholesterol-lowering drug Lipitor (atorvastatin) and trying to terminate Ranbaxy’s rights to sell generic atorvastatin in the US on an exclusive basis for six months.
Concerns over international reference pricing in the EU
An independent report commissioned by the European Parliament’s committee for Environment, Public Health and Food Safety (ENVI) has highlighted some problems with access to medicines due to the widely used practice of international reference pricing within the EU [1].
Generic substitution rates in South Africa
Research carried out by the School of Pharmacy at the North-West University, South Africa, has shown that generic substitution rates for antidepressants increased between 2004 and 2006. Meanwhile antidepressant use decreased over the same period while the average cost decreased in 2005, but increased again in 2006.
Ranbaxy launches generic olanzapine in Spain
Eli Lilly may be facing pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 25 April 2011,the first day after Eli Lilly’s patent exclusivity expired in Spain, Ranbaxy Laboratories announced that it had launched its generic version of the treatment.
Savings due to generic substitution in South Africa
A retrospective analysis of medical claims for antidepressants during 2004–2006 in South Africa calculated potential savings of 9.3% of the actual antidepressant cost over the study period.
Generic prices in Australia slashed
In response to an article by Professor Philip Clarke in the Australian Financial Review titled Time to slash cost of generics, Medicines Australia Chief Executive Dr Brendan Shaw hit back saying that ‘the price of generic medicines on the Pharmaceutical Benefits Scheme (PBS) is already being reduced by as much as 70%.’
Branded generics and generics branding for Merck and sanofi-aventis
While Merck is getting a firm foothold in emerging markets with a branded generics deal with India-based Sun Pharma, sanofi-aventis has decided to unify its generics business under the brand name Zentiva.
The status of generic substitution in South Africa
In South Africa only around 13% of the population live in what we would call ‘first world’ conditions. More than half the population (around 48 million people) live in developing world conditions according to researchers from the School of Pharmacy at the North-West University, South Africa.
Bioequivalence of generic cyclosporine
A clinical trial in allogeneic stem cell transplant (ASCT) recipients found that generic and branded cyclosporine could be considered interchangeable.
FDA rejects pseudoephedrine application due to deficiencies
On 11 March 2011 SCOLR Pharmaceuticals announced it had received a letter from the FDA identifying deficiencies regarding its Abbreviated New Drug Application (ANDA) for its generic extended-release pseudoephedrine.
