Generics

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.

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.