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Protalix BioTherapeutics, Inc. (PLX) Message Board

  • woodbarn woodbarn Jul 14, 2013 3:40 PM Flag

    FDA biosimilar must have same delivery method. Enbrel is injection but Protalix developing oral anti-TNF.

    FDA biosimilar must have same delivery method. Enbrel is injection but Protalix developing oral anti-TNF. That would probably disqualify it as biosimilar. Biosimilar has to be one-to-one replacement and must have same dosage and delivery method. So I think the only drug that Protalix is working on that qualifies as a biosimilar is Pulmozyme.

    Protalix platform is good for biosimilars. Wish they would develop more of them. FDA biosimilars probably will have an accelerated approval process. Slightly modified drugs have to go through full approval process. Not many proteins have patents expired currently, but quite a few will expire within 10-20 years. I think Enbrel expired in Europe. Cerezyme expired. I think there are 10-14 biosimiliars approved in Europe.

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    • Good point. I don't think Amgen has figured out how to make an oral Enbrel yet. So what's it worth to Amgen to have the technology to produce an orally available version of Enbrel?

      or an orally available version of:
      or practically any biopharmaceutical,
      or therapeutic protein,
      or HuMab,
      or HGH,
      or EPO,
      or Insulin?

      for 1/10th the cost of traditionally methods?

 
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