OKs For 16 New Drugs But EMA Holds Firm On Betrixaban & Abaloparatide No

 
• By Maureen Kenny
  
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The European Medicines Agency this month recommended EU marketing approval for a raft of products, including what could become Europe's first two biosimilar versions of the blockbuster drug, Neulasta.

The first two biosimilar versions of Amgen’s blockbuster drug, Neulasta (pegfilgrastim), two drugs with orphan status – one of which was evaluated under the accelerated assessment mechanism, a new antibacterial and two medicines submitted via the EU’s rarely-used pediatric-use marketing authorization (PUMA) pathway. These were among the 16 drugs the European Medicines Agency this week decided should be approved for sale across the EU

Two negative opinions handed down earlier this year were upheld and no decision was taken on another two orphan drugs...

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