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Generics will grab Parkinson’s disease market share

Home/Reports | Posted 10/11/2011

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.

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Pay-to-delay debate hits South Africa

Home/Reports | Posted 04/11/2011

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.

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Overprescribing of drugs ‘chronic’ in Europe

Home/Reports | Posted 04/11/2011

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.

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Clinical biosimilar data should be accessible to all

Home/Reports | Posted 21/10/2011

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].

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The reference pricing system: a socio-economic analysis of the use of low cost medicines in Belgium

Home/Reports | Posted 09/09/2011

Medicines contribute to improving the health status of populations. A recent literature review concluded that medicines are among the most valuable forms of health care and are instrumental in treating various diseases more effectively [1]. Medicines are a major driver of the significant increase in life expectancy observed over the previous decades [2]. The Belgian system therefore tries to help people in socially disadvantaged groups access good quality medicines at affordable prices. This article asks how the system might be improved to better fulfil this objective.

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Not only generics makers are well placed to move into biosimilars

Home/Reports | Posted 19/08/2011

The lucrative biologicals market already boasts five of the world’s top 10 bestselling medicines [1], and by 2015, IMS Health expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals [2]. Although major generics players are well placed to tap into this lucrative market, it is not an exclusive club, and R & D companies also have opportunities [3].

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Problematic patent settlements in EU on the decrease

Home/Reports | Posted 19/08/2011

The European Commission’s (EC) second monitoring exercise of patent settlements in the pharmaceutical sector has shown a continuing decline of potentially problematic settlements under EU antitrust rules.

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The role of generic drugs in the EU

Home/Reports | Posted 12/08/2011

Today, generic medicines play an essential role in treating disease by increasing the accessibility and affordability of modern day pharmaceuticals.

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Diversification of Big Pharma into generics and biosimilars

Home/Reports | Posted 05/08/2011

The infamous patent cliff is upon us and most top multinational companies are highly exposed with thin pipelines [1]. In this current climate, companies can choose to play or defend to optimise their position against generics.

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Registration procedures for generic drugs in the EU

Home/Reports | Posted 05/08/2011

In the EU there are several different routes to marketing authorisation for generic drugs.

Centralised Procedure

Marketing authorisation is issued by the EMA and is valid for the entire EU/European Economic Area.

This procedure is optional for generics:

  • if the reference product is authorised via a centralised procedure (CP)
  • if a CP is in the interests of patients at a EU level.
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Quality control for generic drugs

Home/Reports | Posted 29/07/2011

GMP

Generic medicines manufacturers must comply with the strict rules of good manufacturing practice (GMP). This ensures that all medicines—generic and originator alike—are produced consistently and controlled to stringent standards of quality in accordance with current legislation.

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Generic drugs – registration, quality, value and sustainability

Home/Reports | Posted 08/07/2011

In the current climate of economic downturn and with the impending ‘patent cliff’ threatening many major pharmaceutical companies, generic medicines are increasingly looking like a good option.

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Generic applications in the EU, patents and exclusivity

Home/Reports | Posted 01/07/2011

Types of protection on the originator molecule that have to be taken into account by generic drug manufacturers when filing applications for generic drugs in the EU include the following:

  • patents at the time of marketing
  • supplementary protection certificates at the time of marketing
  • data/regulatory exclusivity at the time of regulatory submission
  • market exclusivity at the time of marketing.
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Big Pharma and the generics industry

Home/Reports | Posted 24/06/2011

What with growth in the global pharmaceutical market slowing and even stabilising and the impending ‘patent cliff’ looming, Big Pharma needs to look for other options.

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Impact of healthcare reforms

Home/Reports | Posted 29/07/2011

Even though global pharmaceutical market growth has stabilised, it still means a rising medicines bill. The global pharmaceutical market is expected to add nearly US$300 billion through 2014, topping US$1.1 trillion [1].

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The growth in the generics industry

Home/Reports | Posted 08/07/2011

During 2010 there was unprecedented activity in the pricing and market access landscape, much of which has aided the growth in the generics industry during 2010. This activity occurred across three broad themes:

Patent cliff and the generics industry

Home/Reports | Posted 01/07/2011

An estimated US$186 billion in sales revenues of patent-protected medicines is likely to be exposed to generic competition between now and 2016 [1].

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A sustainable generics industry in the EU

Home/Reports | Posted 19/08/2011

Today, generic medicines play an essential role in treating disease by increasing the accessibility and affordability of modern day pharmaceuticals. It is therefore essential to ensure that generics can enter the market as soon as possible after patent and data exclusivity protections expire and compete effectively in order to maintain a sustainable generics industry.

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Generics grab 80% share of US market and fill 78% of prescriptions

Home/Reports | Posted 13/05/2011

As more brand-name drugs lose patent protection, use of less expensive generics continues to rise. A new report, published in April 2011 by IMS Health, shows a slowdown in US spending on drugs, but an increase in the percentage of prescriptions filled by generics and a faster rate of capture of market share by generics after patent expiry.

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Global pharmaceutical growth predicted to be 5–7% in 2011

Home/Reports | Posted 07/01/2011

According to IMS Health, global drug sales will rise in 2011 despite patent losses. Although patent expirations and limits on drug spending can hamper growth of drug sales in developed countries, global pharmaceutical sales are nonetheless expected to grow 5–7% in 2011, compared with 4–5% growth in 2010, according to an annual forecast by IMS Health.