French plan to allow generics alarms Big Pharma


In its recent healthcare budget, French lawmakers introduced a measure that will allow pharmacists to substitute generics for prescribed brand-name biotech drugs. This has rattled the industry since France is Europe's #2 pharmaceutical market behind Germany.

A decree must be passed before it becomes effective.

France is the first European country to pursue biologic substitution. Big Pharma fears a domino effect if it is successful despite the heretofore slow uptake of biosimilars.

The initiative applies only to patients starting a new course of treatment. Doctors will still retain the ability to demand the branded product.

Unsurprisingly, Big Pharma is upset at not being consulted prior to the law's passage.

Some analysts believe France could save up to $1.4B by 2020 by using generics.

Substitutions only apply to retail pharmacies. 40% of biotech prescriptions are filled in hospitals.

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Comments (12)
  • Momintn
    , contributor
    Comments (6073) | Send Message
     
    Hopefully consumers have a choice. Go read the article on Bloomberg from earlier in the week about ineffective ingredients in drugs made in low-income countries. I'll stick with Pfizer.
    10 Apr 2014, 10:10 AM Reply Like
  • Qniform
    , contributor
    Comments (4517) | Send Message
     
    It should be made clear that this has nothing to do with current patent and intellectual property protections. The use of the word "generic" is misleading.
    10 Apr 2014, 11:05 AM Reply Like
  • LegoMyGeggo
    , contributor
    Comment (1) | Send Message
     
    Generics and biosimilars are different and whoever wrote that should get a better understanding of this. Generics apply to small molecules while biosimilars are for biologics and the process for developing biosimilars is waaaay different from generics and small molecules.
    10 Apr 2014, 12:37 PM Reply Like
  • SSnape
    , contributor
    Comments (614) | Send Message
     
    I agree with Momintn! "Counterfeit" drugs are a huge global problem and the "cost" is in lives - not in currencies!
    10 Apr 2014, 12:43 PM Reply Like
  • eccomi
    , contributor
    Comments (5) | Send Message
     
    I don't understand this article. I live in Italy, we use generics all of the time, some of them made by TEVA, among other generic companies. It is no big deal, and nobody is up in arms.
    10 Apr 2014, 02:47 PM Reply Like
  • Hector V
    , contributor
    Comments (777) | Send Message
     
    LegoMyGeggo has it right. This is in reference to biologicals that have come off patent. Unlike with small molecules, where it is relatively easy to demonstrate equivalence with the branded product, there has to date been no regulatory path forward for getting biosimilars approved in the US or just about any other country. Cynics will say this is due solely to Big Pharma lobbying, and maybe that's true to some extent, but manufacturing biologicals is much more complicated than small molecules (it's biology, not chemistry), so there are a lot of factors involved, contamination being a big one.
    10 Apr 2014, 05:51 PM Reply Like
  • Paullie99
    , contributor
    Comments (4) | Send Message
     
    How could "big pharma" not know about this legislation. Don't the French allow lobbying?
    Over here the pharmacy lobby would have written the bill. Then maybe it would have been friendlier to the drug makers.
    In most cases generics are fine...if somebody is looking over the makers shoulders for quality. We do...look over....the......quality. Right!
    10 Apr 2014, 08:52 PM Reply Like
  • Hector V
    , contributor
    Comments (777) | Send Message
     
    Paullie,

     

    I'm sure pharmas were aware of the pending action. I've no idea what influence they have in France.

     

    All generic manufacturers that sell into the US are subject to FDA inspections, but it's not like there are inspectors in the plants most of the time. Making biologicals is particularly complex and to date there has been no regulatory path for approving knockoffs of off-patent biologicals. How much of this is really patient safety vs. successful pharma lobbying, I don't know.
    11 Apr 2014, 11:31 AM Reply Like
  • SSnape
    , contributor
    Comments (614) | Send Message
     
    I have never met a generic stem cell.
    12 Apr 2014, 04:02 PM Reply Like
  • pharmaguy
    , contributor
    Comments (175) | Send Message
     
    A lot of misinformation is being posted here. The regulatory path for biosimulars already exists in the EU and there are already 20 biosimulars that being marketed in there.
    It's the FDA that's lagging behind.

     

    Http://http://bit.ly/QhP2Fo
    12 Apr 2014, 05:59 PM Reply Like
  • Hector V
    , contributor
    Comments (777) | Send Message
     
    I stand corrected. I didn't realize the EU had been so out front on this.
    14 Apr 2014, 10:56 PM Reply Like
  • pharmaguy
    , contributor
    Comments (175) | Send Message
     
    Here is the link to marketed biosimulars.

     

    http://bit.ly/QhP2Fo
    12 Apr 2014, 06:00 PM Reply Like
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