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Which drugs are affected by drug shortages in the US

Drug products on the shortages list in the US are concentrated into a small number of disease areas, according to a new report published by IMS Institute for Healthcare Informatics (IMS Institute) [1]. The majority are generic injectables, in fact half of all generic injectables on the US market are on the shortages list, and 16% of drug shortages involve life-saving cancer drugs. This means that the patients most affected by the shortages are mostly acute-care patients being treated in hospitals and out-patient facilities.

Suppliers of products on the drug shortages list in the US

Although overall a large number of producers supply the drugs on the shortages list in the US, most of the drugs are supplied by only one or two companies according to a new report published by IMS Institute for Healthcare Informatics (IMS Institute) [1].

Investigating drug shortages in the US

Drug shortages in the US are at a record high [1] and the issue is becoming of increasing concern for patients, clinicians and policymakers. A new report published by IMS Institute for Healthcare Informatics (IMS Institute) investigates the problem. The report looks at the size of the drug shortages problem, the causes and how shortages could be prevented or resolved in the future [2].

Problematic pharma patent settlements decrease in the EU

A second round of European Commission (EC) monitoring concluded in early 2011. The main objectives of the monitoring exercise were to ‘better understand the use of these type of agreements in the EU and to identify those settlements that delay generic market entry to the detriment of the European consumer possibly in violation of European competition law’. The type of settlements the Commission was looking for were those limiting generic entry and at the same time foreseeing a value transfer from the originator to the generic company.

How originator companies delay generic medicines

Once a medicine marketed by the originator company is no longer protected by patents or other exclusive rights, generics companies can enter the market with a medicine that is equivalent, in terms of efficacy, safety, and quality, to the original. This lowers prices and enhances access to affordable treatments. The generic medicines are always cheaper than the originator brands. In addition, the prices of originator products after two years of generics competition are around 10% lower than at the time of generics entry [1], see Figure 1.

EU investigation tackles pay-for-delay

When the European Commission (EC) was created, one of the founding principles was that of free trade. There should be no barriers to trade within ‘the common market’ as it was called at the time. The Competition Commissioner has previously examined parallel importing in the pharmaceutical sector and has the power to impose large fines.

Generics will grab Parkinson’s disease market share

Overall sales for Parkinson’s disease drugs in seven major countries will decline slightly from US$2.7 billion in 2010 to US$2.6 billion in 2020 in France, Germany, Italy, Japan, Spain, the UK and US, according to a new report from research and advisory firm Decision Resources. The decline is attributed to key therapies losing patent protection and subsequent generics competition.

Pay-to-delay debate hits South Africa

A report issued in August 2011 by the US Federal Trade Commission (FTC), on the short and long-term effects of authorised generics has sparked a debate over how this affects generics in South Africa.

Overprescribing of drugs ‘chronic’ in Europe

Salzburg Medical University, Austria, is the latest body to report the ‘chronic’ overprescribing of drugs for the elderly in Europe. The study found that 36% of prescriptions given to patients with an average age of 82 years were unnecessary, while 30% of drugs prescribed were found to be inappropriate.

Clinical biosimilar data should be accessible to all

Calls are growing for biosimilar manufacturers to publish their data in the public domain, particular when developing versions of monoclonal antibodies (mAbs) that are associated with potential survival benefits [1-3].