Generics
Generics production pulled in different directions
A few months ago it was predicted that generics manufacturers were moving ahead with the development and commercialisation of better manufacturing technologies. The largest firms had now developed to the point at which they can start to develop new manufacturing technologies and thus lower their costs. This was going to lead, on the one hand, to lower prices for products and at the same time, higher profits for those firms able to develop in this way, who were then going to further consolidate their market position.
Tendering for medicines in ambulatory care
Tendering is a mechanism whereby a purchaser buys medicines from the pharmaceutical manufacturer that offers the best bid [1]. Whereas tendering is widely used in the hospital sector, it is only recently being rolled out in ambulatory care in an increasing number of countries with a view to constraining pharmaceutical expenditure. Denmark, Germany and The Netherlands are the countries that have taken up the idea most readily. However, the success of this strategy is not yet clear compared to other European generic medicines pricing policies.
Ranbaxy to launch generic atorvastatin on time
Ranbaxy Laboratories will release a generic version of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) in the US at the end of November 2011 as planned, according to a report in the Japanese newspaper Nikkei.
US drug shortages prompt oncologists to go into drug manufacture
Drug shortages in the US are at a record high and there appears to be no quick solution to the problem. Legislation, government stock-piling and physicians importing or even manufacturing drugs are just some of the solutions being proposed.
Sanofi France to make generic atorvastatin
The French daily newspaper, Les Echos, reported on 1 September 2011 that sanofi France (sanofi) had reached an agreement with Pfizer to produce generic versions of the blockbuster cholesterol drug Lipitor (atorvastatin).
Ranbaxy launches generic esomeprazole in the UK
India-based Ranbaxy Laboratories announced on 5 September 2011 that it had successfully launched esomeprazole magnesium 20 mg and 40 mg tablets in the UK.
Teva continues its fight to prevent generic glatiramer acetate
Teva Pharmaceutical Industries (Teva) has not given up the fight to keep generics competition away from its blockbuster drug, Copaxone (glatiramer acetate). The company announced on 29 August 2011 that a US federal court had rejected interpretation claims from its challengers in patent infringement lawsuits over its proprietary multiple sclerosis treatment, setting a trial date of 7 September 2011.
New Spanish prescribing laws to promote generics
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.
Ranbaxy may sell its generic atorvastatin exclusivity
According to Credit Suisse analysts, Ranbaxy Laboratories (Ranbaxy) may sell its rights to make a generic version of Pfizer’s cholesterol blockbuster Lipitor (atorvastatin), should it look unlikely to gain FDA approval in time for the planned November 2011 launch.
Generics manufacturers do not have to change drug safety labels in the US
A landmark ruling from the US Supreme Court has decided that generic drug manufacturers do not have to change their drug’s safety label, even if stronger safety warnings are found to be required [1- 2]. This is the opposite of a ruling in 2009 that decided that patients could sue the manufacturer of a brand-name drug if its safety label is found to be inadequate, e.g. when new drug-related risks are discovered after the drug has made it to market [3, 4].
