Catch-up legislation from the EU has swept away the handicap on European generics companies, allowing them to research copycat drugs before patent expiry.
As a result of the EU directive, the EU's generics market, which is currently worth only 10 per cent of the total €70 billion European pharmaceutical market, is set to skyrocket.
According to US figures, $50 billion (€42.7 billion) worth of branded drugs are due to lose patent exclusivity over the next five years.
In the next year alone, $11 billion in drug sales are expected to lose patent, with generic alternatives becoming available for at least 15 branded drugs.
Until now US generics companies have had a major head-start in launching generics onto the market – a process that can take up to six years.
The landmark "Bolar provision" eliminates the patent infringement risk that EU generics companies previously faced if conducting studies, tests or trials on a generic version of a drug before the brand-name product's patent protection expired.
The exemption will finally allow European generics companies to compete on an even playing field with the US, where a similar exemption has been in place for the past 20 years as part of what is known as the Hatch-Waxman Act.
Insider has noted that a number of Big Pharmas have been quietly moving into generics in a big way. If you cant beat them, join them.
Source: DrugResearcher.com
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