Generics

Savings due to generic substitution in South Africa

Generics/Research | Posted 06/05/2011

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

Generics/News | Posted 06/05/2011

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

Generics/News | Posted 06/05/2011

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

Generics/Research | Posted 29/04/2011

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

Generics/Research | Posted 29/04/2011

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

Generics/News | Posted 29/04/2011

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

Generics/News | Posted 22/04/2011

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

Generics/News | Posted 15/04/2011

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

Generics/General | Posted 15/04/2011

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

Generics/General | Posted 08/04/2011

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

Generics/News | Posted 08/04/2011

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

Generics/Research | Posted 01/04/2011

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

Generics/General | Posted 01/04/2011

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

Generics/News | Posted 01/04/2011

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

Generics/News | Posted 01/04/2011

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

Generics/News | Posted 25/03/2011

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

Generics/News | Posted 18/03/2011

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

Generics/Research | Posted 18/03/2011

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.