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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].

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

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.

Not only generics makers are well placed to move into biosimilars

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].

Problematic patent settlements in EU on the decrease

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.

The role of generic drugs in the EU

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

Diversification of Big Pharma into generics and biosimilars

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.

Registration procedures for generic drugs in the EU

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.

Quality control for generic drugs

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.

Generic drugs – registration, quality, value and sustainability

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.

Generics News Research General

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Biosimilars News Research General

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