Generics
Mylan tries to block Ranbaxy’s Lipitor exclusivity
Cholesterol fighter Lipitor (atorvastatin calcium) has been the worlds ‘best-selling drug’ for the last 10 years, and has been a major source of income for the world’s biggest drug company, Pfizer. Lipitor was released in 1998, and by 2006 it had reached peak sales of US$12.9 billion, accounting for 27% of the company’s revenue. In 2010, with US$10.8 billion in sales, Lipitor still accounted for 15.8% of total revenue, even with the addition of Wyeth’s operations.
Germany tightens controls on pharmaceutical prices
The German government is contemplating pharmaceutical price control legislation as it battles soaring drug spending. On the one hand Germany is keen to promote the use of generic drugs and generic medicines have already achieved high penetration—75% by volume in 2009. This highlights opportunities for generic manufacturers in Europe's largest, albeit competitive, drug market.
Topotecan market too hot for Sun
Sun Pharmaceutical Industries withdrew its marketing authorisation application for Topotecan SUN on 17 February 2011. EMA was formally notified by Sun of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Topotecan SUN 1 mg and 4 mg powder for concentrate for solution for infusion.
Brand-name versus generic drug costs
The Blue Cross Blue Shield of Michigan, an American healthcare insurance company, has collected data on the top 25 brand-name drugs with available generic counterparts.
India under attack
India is coming under attack from Big Pharma from all angles it seems. On the one hand the Indian Government has alleged that multinational companies are campaigning against the country’s domestic pharmaceutical industry due to India’s increasing generic global presence. Then on the other hand Novartis has been asked to end its challenge to Indian patent law, with claims that its action could hinder global access to medicine.
Value-based pricing – the concept
The concept of value-based pricing (VBP) is outlined. A key purpose of the VBP system is to assess over time whether the drug has achieved its intended goal and justified its cost.
EU-India free trade agreement and impact on generics
Opposition is mounting against the imminent EU-India free trade agreement (FTA) from both AIDS activists and industry. Protestors claim that the agreement will harm access to affordable medicines.
Indian generics companies to strengthen in 2011
Dispute with EU resolved
The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe en route to Africa and Latin America. In 2009, the EU repeatedly seized generic drugs originating in India as they passed through European ports on their way to Brazil.
Sun Pharma continues to expand its generics portfolio
Sun Pharma is keeping up the momentum in the generics market with several new generics recently gaining FDA approval and with an extensive pipeline on the way. The latest generics to come out of the company include drugs for the treatment of hypertension, allergic rhinitis and depression.
Strong lobbying by Canadian Generics Association
The President of the Canadian Generic Pharmaceutical Association (CGPA), Mr Jim Keon, has been speaking up on behalf of Canadian generic companies in two recent statements. Canada and the EU are currently in negotiations for a comprehensive economic and trade agreement, which they hope to conclude before the end of 2011.
European Parliament gives go-ahead for EU patent
Despite doubts over the legality of the proposed linguistic regime, the European Parliament gave its green light on 15 February 2011 for use of a rarely used provision of the Lisbon Treaty known as ‘enhanced cooperation’ to launch a common EU patent system without Italy and Spain on board.
Efficacy and tolerability of generic and branded atorvastatin
In a study carried out in Korean patients the efficacy and tolerability of generic and branded atorvastatin was evaluated and found to be similar in Korean patients at high risk for cardiovascular events.
Generic substitution in Norway
Using a dataset extracted from the Norwegian prescription database containing all prescriptions written in the period January 2004 to June 2007, an analysis was carried out on two brand-name and two generic statin drugs used to treat high cholesterol and showed that prices have a clear impact on generic substitution [1].
Teva again files citizen petition against generic Copaxone
Teva Pharmaceutical Industries announced on 12 December 2010 that the company had filed another Citizen’s Petition (CP) with the FDA requesting that the agency refuse to approve any abbreviated new drug application (ANDA) for generic versions of Copaxone (glatiramer acetate injection).
Teva setbacks
Teva axes 200 jobs as facility remains closed
After stopping all production at its plant in Irvine, California, USA; in April 2010, Teva announced on 20 January 2011 that all 200 jobs will go.
Race you for US$1.8 billion
The market for proton pump inhibitor pantoprazole in the US is estimated to be worth Euros 1.3 billion a year, and drug companies are scrambling to sell generic versions now that Pfizer’s patent has expired.
Generics to cash in on swine flu epidemic
Indian drug manufacturer Natco Pharma has filed an abbreviated new drug application (ANDA) with the FDA for a generic version of Tamiflu (oseltamivir), challenging Gilead Science’s patent protection on the drug.
Impact of generic substitution in Finland
Mandatory generic substitution was introduced in Finland on 1 April 2003. A recent study compared the impact of generic substitution on both originator and generic pharmaceutical companies in Finland.
The biggest US patent expiries of 2010
While the much talked-about patent cliff will not hit until 2011, 2010 has been witness to patent expirations of some of the industry’s blockbuster drugs.
European Commission to investigate patent settlements again
The European Commission (EC) has once again requested information from pharmaceutical companies regarding patent settlement agreements concluded in the European Economic Area (EEA) in 2010 between originator and generic companies.
New ANDAs and patent challenges for Impax Laboratories
Impax Laboratories is facing a whole barrage of patent litigation following its latest Abbreviated New Drug Application (ANDA) filings and approvals with the FDA.
Birth pangs of the Medicines Patent Pool
The Medicines Patent Pool (MPP) is an initiative designed to streamline patent licensing for generic versions of patented HIV treatments, in order to obtain lower prices for medicines in countries where people are unable to afford the drugs.
Generic substitution causing confusion
How do customers and pharmacists really experience generic substitution? This is the question asked in a recent research article [1].
Generic and branded acetylcysteine bioequivalent
A single-dose study of acetylcysteine 600 mg found that three tablets of 200 mg of the generic formulation given orally were bioequivalent to a single 600 mg tablet of the branded drug.
Impax challenges Simcor patent
On 26 November 2010, generic drug maker Impax Laboratories announced that it is challenging the patent covering Abbott Laboratories’ cholesterol-treatment drug, Simcor (niacin/simvastatin).
The therapeutic equivalence of brand-name and generic narrow therapeutic index (NTI) cardiovascular drugs
There are many physicians and patients who have concerns that the bioequivalent generics may not have an equivalent nature in terms of their clinical effect and benefit. In the realm of cardiovascular disease, this can include such parameters as heart rate, blood pressure and laboratory measurements.
The therapeutic equivalence of antiplatelet agents, ACE-inhibitors, statins and alpha-blockers
The potential changes in pharmacy formulary policy, due to the availability of generic versions of cardiovascular drugs, should be based on as much evidence as possible.
Pharmacy chains in Norway do not stock generics
It turns out that pharmacy chains in Norway do not stock the cheapest generic products. This finding came after the Norwegian Medicines Agency (NoMA) investigated after receiving a complaint from the British generics manufacturer Arrow that its products were not sold in branches of the three largest pharmacy chains in Norway: Apotek1 (Phoenix), Vitusapotek (Celesio) and Alliance/Boots Apotek (Alliance Boots).
The clinical equivalence of generic and brand-name calcium channel blockers
Companies seeking to launch a generic drug are required to submit a dossier to authorities, which does not contain the results of extensive preclinical and clinical testing demonstrating safety and efficacy in the target population, as is the case with novel drugs, but only limited data and evidence demonstrating the fundamental premise that the generic is bioequivalent to its brand-name counterpart.
Medicines pricing policies in Europe: a review
The OECD countries spent 4.6% more per capita per year on pharmaceuticals from 1995 to 2005 although the annual average economic growth was only 2.2% during the same period [1].
Profits for generics’ giant Teva soar
Israel-based generics’ giant Teva Pharmaceutical Industries has reported a third quarter 2010 profit rise of 47%, mainly attributed to sales of its multiple sclerosis drug Copaxone (glatiramer acetate), its acquisition of Ratiopharm and generic launches in the US.
The generic drug wars: deeply discounted medication
Fierce competition among major pharmacy chains in the US, such as CVS, Walgreens and Walmart, has led to a generic prescription pricing war with unclear public health implications.
Ranbaxy gets 180-day exclusivity for Alzheimer’s generic
On 30 November 2010, generics’ giant and India’s largest pharmaceutical manufacturer, Ranbaxy Laboratories, announced the launch of a generic version of Pfizer’s blockbuster Alzheimer’s treatment, Aricept (donepezil hydrochloride), in the US.
The clinical equivalence of brand-name beta-blockers and their generic counterparts
The healthcare systems of the world are all under pressure to reduce costs and using generic substitution for the initially prescribed, more expensive equivalents is an obvious area to investigate. However, as a report reiterated in 2010, treatment decisions should not be based on economic grounds alone, for this would not be in the patient's best interest and would therefore be unethical. What is needed is an opinion based on the evidence available regarding therapeutic equivalence [1].
Are generic diuretics clinically equivalent to their brand-name counterparts for the management of cardiovascular disease?
Prescription costs are rising, mainly due to brand-name drugs recouping their investment during the period of patent protection and market exclusivity. For this reason, many payers and prescribers encourage use of the cheaper generic versions [1]. This has been found to have another positive consequence, namely the increased accessibility to prescription treatments and an increased compliance with drug regimens, particularly in the case of chronic conditions [2, 3].
Sun gains tentative approval for generic Crestor
Indian-based Sun Pharmaceutical Industries announced on 29 September 2010 that the FDA had granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of IPR Pharmaceuticals’ (a part of AstraZeneca) anti-cholesterol drug Crestor (rosuvastatin calcium).
Generic or brand-name drugs for cardiovascular disease? Does the evidence match current opinion?
Cardiovascular drugs constitute a large proportion of outpatient prescription drug spending.
The rise in power of generic drugs
With shrinking pipelines, the impending expiration of many drug patents, and the global economic downturn experienced in the last two years causing prescription payers to face budget cuts, generic drugs are becoming an increasingly large player in the economics of the global pharmaceutical industry.
WHO prequalification programme for APIs
The WHO initiated on 21 October 2010 a pilot prequalification programme for selected active pharmaceutical ingredients (APIs) used in drugs for HIV and related diseases, antimalaria and anti-tuberculosis medications.
FDA considering tighter controls on generics
The FDA may tighten standards for how closely generic drugs resemble brand-name equivalents. This comes as a result of complaints from both patients and employees of generic drugmakers that some of the medicines do not work as well as the originals.
Generic combination antibiotic launched in US
On 26 October 2010, Hospira announced the launch of its combination antibiotic (piperacillin and tazobactam) for injection in the US. The medication is a generic version of Zosyn, the world’s leading injectable antibiotic, from Pfizer (Wyeth). Piperacillin and tazobactam injection posted sales in the US in 2009 of more than US$855 million.
Tackling counterfeit drugs in China
The Chinese State Council, or cabinet, said on 19 October 2010 it would “launch a special campaign to fight intellectual property rights infringement and the manufacture and sale of counterfeit goods” at a meeting chaired by Premier Wen Jiabao. The six-month campaign, which includes making sure government organisations use genuine software, will begin at the end of October 2010, said the State Council.
India’s top pharma company strengthens ties with South Africa
Generics’ manufacturer Cipla is a prominent Indian pharmaceutical company, best known outside its home country for manufacturing low-cost anti-AIDS drugs for HIV-positive patients in developing countries. Cipla exports to 170 countries and its manufacturing facilities are approved by WHO, US FDA, UK MHRA and other major agencies. Cipla was responsible for lowering the cost of triple therapy antiretroviral (ARV) to less than US$1 per day and is, in partnership with the Clinton Foundation, to supply ARVs to third world countries.
A view from South Africa
Aspen Pharmacare, Africa’s biggest generic drugs company, reported a 24% rise in full-year profit at the end of June 2010, boosted by its South African unit, and says it expects strong demand in the coming year.
Who are the GPhA and what do they do?
The Generic Pharmaceutical Association (GPhA) is a group that represents the interests of generic drug manufacturers in the US. To achieve this they pursue an active lobbying policy. They are currently in talks with the FDA to improve the process by which it approves generic medicines. Generic pharmaceuticals account for 75% of the prescriptions dispensed in the US but consume just 22% of the total drug spending.
Apotex loses fight over Plavix patents
Apotex was told to pay sanofi-aventis (sanofi) and Bristol-Meyers Squibb (BMS) a whopping US$442 million (plus interest) for violating patents on the blockbuster blood-thinner Plavix (clopidogrel bisulphate).
Brand loyalty, generic entry and price competition in the US
In a new working paper from the US National Bureau of Economic Research researchers investigated brand loyalty, generic entry and price competition in the 25 years since the 1984 Waxman-Hatch legislation came into force.
FDA grants approval for generic lansoprazole
Teva Pharmaceutical Industries announced on 18 October 2010 that it had received FDA approval for its Abbreviated New Drug Application for its generic version of Takeda's Prevacid (lansoprazole) SoluTab.
Teva brings another action against Mylan
In October 2009, Teva Pharmaceutical Industries filed a lawsuit against Mylan for infringement of multiple patents, with respect to patents on its glatiramer acetate drug–Copaxone. The patents cover pharmaceutical compositions containing it, methods of using it and processes for making it. Those patents expire in May 2014 and September 2015. No trial date is scheduled.
What is the incremental cost-effectiveness ratio (ICER)?
The incremental cost-effectiveness ratio (ICER) often comes up when talking about drug comparisons, but what is it and how does it relate to medicines?
Ranbaxy beats Teva to Alzheimer’s drug
Aricept (donepezil hydrochloride), Eisai Pharmaceutical’s biggest selling drug, comes off patent in the US in November 2010. Thereafter donepezil hydrochloride may be sold as a generic drug. Teva has applied to sell donepezil, but the FDA granted Ranbaxy first access to the lucrative market in a letter dated 17 September 2010.
An ageing population: generics and biosimilars could be the solution
On 17 October 2010 the European Generic Medicines Association (EGA) organised an event to discuss patient access to affordable treatments and healthcare sustainability in view of an increasingly ageing population.
Canadians pay almost twice as much as Americans for generics
A new study released on 13 October 2010 by the Canadian Fraser Institute finds that Canadians pay far higher prices, in fact almost double, for generic drugs than patients in the US.
Go Perrigo!
Generic drug maker Perrigo has made it to Fortune magazine's top 100 fastest growing companies in the US. Fortune is a business magazine especially known for ranking companies by revenue. So there is some rejoicing in Michigan as the local hero has now received national acclaim.
FDA user fees for assessing generic drugs
The FDA is beginning a long-awaited attempt to create a system of user fees for assessing generic drugs. The US agency has a backlog of more than 2,000 products to review and has been short of funds for years. But things are never straightforward…
Slow response to internet sales of fake pharmaceuticals
If you are reading this news online, you are surely aware that many sites claim to sell “generic medicines” “without prescription” over the internet. Police and authorities have noticed as well, but do not know how best to tackle these lucrative scams.
Teva continues to expand
The world's largest generic pharmaceutical company, Israeli-based Teva Pharmaceutical Industries, is investing Euros 42 million to expand its production plant in Stouffville, Canada. At the same time Ontario is providing a Euros 4.8-million grant to Teva Canada, which will retain 182 high-skilled workers and hire 20 new employees.
Comparison of biosimilar and branded vancomycin
Despite demonstrating pharmacological equivalence, researchers have found biosimilar vancomycin exhibited inferior antimicrobial activity compared with the branded product.
Teva challenged over 180-day marketing exclusivity
Canadian generics’ manufacturer Apotex has asked the US Supreme Court to hear a case that could have a lasting impact on how marketing exclusivity is awarded to generic-drug manufacturers by the FDA.
Japan’s generics sector set to grow
Japan is currently the world’s second largest pharmaceutical market, with annual sales of approximately Yen 8,850 billion. Around 8% of its prescription drug sales (20% in sales volume) are generics.
Tentative approval for more new Sun Pharma generics
Sun Pharma is not slowing down with the number of new generic medication introductions. The latest generics to come out of the company include versions of riluzole hydrochloride and rosuvastatin.
Incentives to use generic medicines
A variety of financial and non-financial incentives are intended to encourage generic prescribing. Physician budgets are used by Germany and UK and seem to encourage generic prescribing. Assistance in terms of electronic prescribing, medicines databases, audit and feedback on prescribing data, guidelines and formularies tend to be voluntary and have a limited impact. Denmark and the UK teach medical students to prescribe by INN rather than brand name. Portugal requires prescription by INN if a generic product exists. Physicians see this as a restriction on their prescribing freedom in Belgium and France and resist such moves.
An industry view of generic manufacturing
Research and development of innovative medicines are becoming more challenging, with only 29 medicines with new chemical entities launched in 2006. The dwindling pipeline of new innovative medicines reduces the number of new chemical entities that can be developed when patents on innovative medicines expire in the future. Manufacturers of innovative medicines attempt to extend the period of patent protection by either launching a new dosage, a sustained-release version, a new indication, a single isomer version or a combination medicine. These strategies delay the market entry of generic medicines. As generic competition primarily takes place in the market for prescription medicines, some manufacturers of originator medicines have switched their medicines from prescription to over-the-counter status, e.g. simvastatin 10 mg in UK.
Pricing strategies in generic medicines
Eighty two per cent of countries impose pricing regulation while 18% opt for free market competition to control prices. Of the countries that regulate prices, 36% set the price of generic medicines at a predetermined percentage below the originator price. For instance, the minimum price difference between originator and generic medicines was 20% in Italy in 2004. In 21% of countries, the generic medicine price is based on the average price of medicines in a selection of countries. Other mechanisms used to set generic medicine prices are a maximum price (19% of countries) and a negotiable price (12% of countries).
Generics in The Netherlands
The market for generic medicines in The Netherlands ambulatory health care is developing, with more being used, more companies supplying generic medicines and prices tumbling. This is despite the restriction on the reimbursement of hypnotics and tranquilisers on the basic insurance from 1 January 2009. Reimbursement in this category fell by 25%, from Euros 612 million in 2008 to Euros 459 million in 2009.
Celgene and Natco in generic lenalidomide battle
Indian generics’ manufacturer Natco Pharma (Natco) has filed an abbreviated new drug application (ANDA) with the FDA seeking approval to sell a generic version of Celgene Corporation’s (Celgene’s) flagship blood cancer drug Revlimid (lenalidomide), before its patent protection expires.
What is ‘tentative approval’ and how does it affect generics?
Tentative approval by the FDA enables generics access to poor nations under a US initiative, which allows sale of generics to treat conditions where there is a significant public health impact, even though the originator drugs are still under patent protection.
Pharma price-fixing under renewed investigation
Some of the world’s biggest drug companies are having once again to face up to price-fixing allegations thanks to the Supreme Court of California. These allegations were dismissed by a lower court two years ago. The suit claims that the 18 drug manufacturers, including Pfizer, GlaxoSmithKline, AstraZeneca, Merck and Eli Lilly amongst others, not only set artificially high prices, but also conspired to keep cheaper Canadian drugs off the US market and to stave off generic competitors.
Drug recalls and generic medicines
In 2009 there were a record number of drug recalls according to Health Reform Watch. There were an amazing 1,742 drug recalls in 2009 compared to 426 in 2008.
International trends in generics: India
South Africa, home to 5.7 million HIV-positive people – more than any other country in the world – gives AIDS patients free drugs, most of which are generics that come from India. This is just one country, but representative of many that are keen to buy low-priced generic medicines from India. So much so that India now produces a quarter of the world’s generic medicines.
Can we have our cake and eat it?
Managing the cost of pharmaceutical expenditure is entirely the competence of individual EU Member States. As a result, Europe has developed into a patchwork of different systems of pharmaceutical pricing and reimbursement.
International trends in generics: the EU
Few studies have conducted an international price comparison of generic medicines as it is hard to access comparable data. A 2007 study by Prof. Dr. Steven Simoens examined national pricing policies in some EU countries and related them to generics prices (see Table 1).
Sun Pharma adds generic tamsulosin and rivastigmine to portfolio
Sun Pharma is gathering speed with a barrage of generic versions recently coming onto the market and with an extensive pipeline on the way. The latest generics to come out of the company include versions of tamsulosin and rivastigmine.
Sun and Teva losing battle over generic Protonix
On 19 July 2010, it was announced that a US court had denied a motion by India’s Sun Pharmaceutical Industries and Israel-based Teva Pharmaceutical Industries to reverse the earlier verdict of patent infringement on Pfizer/Nycomed’s gastrointestinal drug Protonix (pantoprazole).
New EGA chair to study generic medicines policies
On 8 July 2010, Professor Steven Simoens was inaugurated as the new European Generic medicines Association (EGA) chair for ‘European policy towards generic medicines’ at the Catholic University in Leuven, Belgium. This chair is funded by the EGA in collaboration with Mylan, Ratiopharm, Sandoz International and TEVA Pharmaceuticals for a five-year period.
Court upholds decision against AstraZeneca’s omeprazole
On 1 July 2010, the General Court of the European Union (GCEU) upheld the decision of the European Commission (EC), which found that AstraZeneca had abused its dominant position by preventing the marketing of generic versions of Losec (omeprazole).
Generics lose battle against AstraZeneca’s Crestor (rosuvastatin)
On 30 June 2010, AstraZeneca announced that a court in the US had overruled challenges, from a number of generic producers, to the patent on its blockbuster cholesterol drug, Crestor (rosuvastatin).
Ranbaxy launches generic atorvastatin in South Africa
Sales of Pfizer’s Lipitor (atorvastatin), the world's biggest-selling drug, are expected to take another blow as Ranbaxy South Africa (Ranbaxy SA) announced the launch of a generic version of atorvastatin onto the South African market on 8 June 2010.
Approval of ‘hybrid generic’ PecFent (fentanyl) in EU
On 25 June 2010, Archimedes Pharma (Archimedes) announced that it had received a positive opinion from the CHMP of the EMA for its ‘hybrid generic’ PecFent (fentanyl).
Teva changes generic Yaz contraceptive label
Israeli generic giant Teva Pharmaceuticals has agreed to change the labelling on its generic oral contraceptive, Gianvi, after Bayer Schering Pharma (Bayer) filed a lawsuit accusing the company of falsely claiming its drug was identical to Bayer’s Yaz.
