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Biosimilars: key players and global market trends

Home/Reports | Posted 01/06/2012

Biosimilars are approaching a turning point in their evolution, although positive moves are being made, there is still much that has to change in order to create a global market that can sustain biosimilars [1].

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Biosimilars policies in Italy

Home/Reports | Posted 18/06/2012

According to the 2011 report by Rovira et al., biosimilars commercialised in Italy show a low penetration both in the total market (0.01%) and in the biological market (0.3%). However, in order to try and promote the uptake of biosimilars, a specific initiative is now being used during the negotiation procedure of biosimilars giving progressive price reductions [1].

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Generics saved US healthcare system and patients US$1 trillion

Home/Reports | Posted 10/08/2012

According to a new report from the Generic Pharmaceutical Association (GPhA), released on 2 August 2012, generics saved the US healthcare system and patients US$1 billion every other day―totaling US$193 billion in 2011 and more than US$1 trillion over the last 10 years (2002–2011).

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Rise in US spending on generics: a buoyant market as patents expire on brand-name drugs

Home/Reports | Posted 22/06/2012

A new IMS report notes a rise in spending on generic medicines in the US to 27%, or US$75 billion, and looks at the main changes driving the trend.

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More capacity needed in clinical trial review for national approval of biosimilars

Home/Reports | Posted 22/06/2012

The need for National Regulatory Authorities to build capacity in clinical trials review, and for WHO to continue monitoring regulatory procedures for the evaluation of biosimilars were among the main recommendations of a workshop to discuss the implementation of WHO guidelines on evaluating biosimilars in Seoul, Republic of Korea, 24–26 August 2010.

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WHO guidelines on biosimilars: case studies and discussion highlights

Home/Reports | Posted 18/06/2012

The experiences and progress of different countries in implementing WHO guidelines on evaluating biosimilars were the focus of a workshop hosted jointly by WHO and Korea Food and Drug Administration (KFDA).

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Global generics markets predicted to grow to US$221 billion by 2016

Home/Reports | Posted 04/05/2012

The global markets for generic drugs will continue to grow despite cost reduction measures from governments and healthcare payers in many markets.

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Biosimilars marketed in Europe

Home/Reports | Posted 18/05/2012

Europe was the first region to approve and introduce biosimilars into the market back in 2006, and now in 2012 the continent is the largest biosimilars market in the world, with 14 biosimilars approved by EMA.

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Biosimilars use in Europe

Home/Reports | Posted 25/11/2011

A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration process were issued in 2006. However, acceptance and use of biosimilars within Europe varies by country.

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Oncologists inconsistent in how they judge value of high-cost cancer drugs

Home/Reports | Posted 27/04/2012

A survey of oncologists in Canada and the US has shown that physicians are inconsistent when deciding how long an expensive new cancer therapy should extend a person’s life before the cost of the therapy is justified. The results of the survey also showed the benefit that oncologists demand from new treatments in terms of length of survival does not necessarily increase according to the price of the treatment [1].

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AARP report highlights importance of generics

Home/Reports | Posted 16/03/2012

According to a report issued on 6 March 2012 by AARP (formerly the American Association of Retired Persons) the prices of drugs used most widely by older Americans rose by nearly 26% from 2005 to 2009 or in other words nearly twice the rate of inflation.

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UK gets value for money for its medicines

Home/Reports | Posted 02/03/2012

A UK Department of Health (DoH) report confirms that the voluntary pricing agreement between the DoH and the pharmaceutical industry is working and that medicines are good value for money for the National Health Service (NHS).

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Early warning system for drug shortages in the US

Home/Reports | Posted 17/02/2012

In response to the record high numbers of drug shortages in the US [1] the IMS Institute for Healthcare Informatics (IMS Institute) has published a list of recommendations consisting of an ‘early warning system’ for drug shortages [2].

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Volume and sales of drugs on the shortages list in the US

Home/Reports | Posted 10/02/2012

Despite record numbers of drug shortages being reported in the US [1], on the whole, over the past five years the supply of these drugs to healthcare providers–hospitals, clinics, pharmacies–has increased, according to a new report published by IMS Institute for Healthcare Informatics [2].

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Which drugs are affected by drug shortages in the US

Home/Reports | Posted 27/01/2012

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.

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Suppliers of products on the drug shortages list in the US

Home/Reports | Posted 03/02/2012

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].

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Investigating drug shortages in the US

Home/Reports | Posted 20/01/2012

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].

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Problematic pharma patent settlements decrease in the EU

Home/Reports | Posted 13/01/2012

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.

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How originator companies delay generic medicines

Home/Reports | Posted 16/12/2011

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.

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EU investigation tackles pay-for-delay

Home/Reports | Posted 09/12/2011

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.