Generics/General

Industry adjustments as patents expire

Generics/General | Posted 14/10/2011

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

New Spanish prescribing laws to promote generics

Generics/General | Posted 02/09/2011

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.

Pilot programmes between EMA, FDA and TGA a success

Generics/General | Posted 19/08/2011

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.

Market share of generics set to rise as blockbuster patents end

Generics/General | Posted 05/08/2011

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].

TRIPS and access to essential medicines

Generics/General | Posted 29/07/2011

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.

Europe’s industry concerned about converging prices and patient access

Generics/General | Posted 20/05/2011

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’.

Concerns over international reference pricing in the EU

Generics/General | Posted 13/05/2011

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].

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.

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.

Japan’s generics sector set to grow

Generics/General | Posted 29/10/2010

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.

The biggest US patent expiries of 2010

Generics/General | Posted 04/03/2011

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.

Birth pangs of the Medicines Patent Pool

Generics/General | Posted 25/02/2011

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.

Who are the GPhA and what do they do?

Generics/General | Posted 10/12/2010

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.

What is the incremental cost-effectiveness ratio (ICER)?

Generics/General | Posted 03/12/2010

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?

Slow response to internet sales of fake pharmaceuticals

Generics/General | Posted 08/11/2010

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.

Tentative approval for more new Sun Pharma generics

Generics/General | Posted 20/10/2010

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.

Pharma price-fixing under renewed investigation

Generics/General | Posted 10/09/2010

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.

Generics in The Netherlands

Generics/General | Posted 01/10/2010

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.

International trends in generics: India

Generics/General | Posted 03/09/2010

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.

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