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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.

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…

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.

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.

Big shifts in generics shares due to Dutch preference policy

The percentage of generic prescribing in The Netherlands increased in 2009 from 56.3– 57.1% according to the Dutch Stichting Farmaceutische Kengetallen (SFK), as published in Pharmaceutisch Weekblad of 12 March 2010.

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.

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.

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).