Not Just Herceptin Biosimilar: Additional 12 Drugs Set For EU Marketing Approval After CHMP Nod

 
• By Maureen Kenny
  
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New treatments for plaque psoriasis and ovarian and prostate cancer join the first Herceptin biosimilar and several other products in garnering recommendations for EU marketing approval at September's meeting of EMA's key scientific committee, the CHMP. No decision was taken on Roche’s new MS drug, Ocrevus, and earlier negative opinions of three other products were upheld.

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The European Medicines Agency’s key scientific committee, the CHMP, has recommended for approval throughout the EU 13 of the 14 initial marketing authorization applications that it reviewed at its September meeting. Products that can now look forward to securing formal approval within months include Ontruzant from Samsung Bioepis Co. Ltd., the first biosimilar version of Roche’s blockbuster breast cancer drug, Herceptin (trastuzumab) recommended by the committee.

There was good news as well for Johnson & Johnson, Tesaro Inc. and GlaxoSmithKline PLC, among others.

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