Generic drugs – registration, quality, value and sustainability

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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.


Many of the pharma giants are already turning to generics. Merck now has a generics unit Merck KGaA, Sanofi-aventis has its own branded generics division Greenstone, and Novartis has its Sandoz generics division. One thing is certain the patent cliff will not go away and Big Pharmas have to diversify or lose out.

However, it is not always that simple. Many things need to be taken into consideration concerning the regulations and the registration procedure for generics in the EU. What are the relevant patents and data exclusivity on the originator molecules that have to be taken into account? Are there also supplementary protection certificates and market exclusivity to take into account? What are the relevant registration procedures? What are the merits of the different procedures and which procedures are preferable for generic medicines?

There is also the issue of the quality requirements for generic medicines. What are the quality requirements? How can the supply chain be managed and the integrity of the active pharmaceutical ingredients be maintained?

There is the question of where does the value of generics lie? Generic medicines play an essential role in treating disease by increasing the accessibility and affordability of modern day pharmaceuticals, but where exactly do the benefits come from?

Last, but certainly not least, is the question of whether the generics industry is sustainable or not? Access to market, pricing and competition all have a role to play here, but most importantly governmental policies can have a big influence.

These are just some of the questions addressed in the series of five articles that follow.

Related articles

A sustainable generics industry in the EU

The role of generic drugs in the EU

Registration procedures for generic drugs in the EU

Quality control for generic drugs

Generic applications in the EU, patents and exclusivity

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