FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

European Parliament Evens Scales for Generics Makers With New SPC Waivers

April 25, 2019
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European drugmakers will be allowed to make generics and biosimilars after the European Parliament voted in favor of manufacturing waivers that will allow their export.

The vote amends EU regulations to allow generics and biosimilars manufacturers to obtain waivers to make products otherwise protected by supplemental protection certificates. The certificates extend patent rights for specific drugs that are given authorization by regulatory agencies. After Wednesday’s votes, European drugmakers can sell generics or biosimilars if they’re exporting to countries where the certificate has expired or never existed.

EU manufacturers may also make protected products for stockpiling efforts during the final six months of their certificate protection prior to launching a product on the EU market.

The European Commission says the reform will “remove a major competitive disadvantage of EU manufacturers compared to manufacturers based in non-EU countries and ensure a better deal for patients,” estimating a potential $1.13 billion in sales and up to 25,000 new jobs over the next ten years.

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