Biosimilar Enbrel from Novartis accepted by FDA! Bye bye INBU!

Discussion in 'Amgen' started by anonymous, Oct 3, 2015 at 5:14 AM.

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  1. anonymous

    anonymous Guest

    The U.S. Food and Drug Administration has accepted Novartis (NOVN.VX) unit Sandoz's regulatory submission for approval of a biosimilar copy of Amgen's (AMGN.O) blockbuster Enbrel drug, the Swiss drugmaker said on Friday.

    Biosimilars aim to copy biologic products, which are made inside living cells, but they can never be exact duplicates, so biosimilar manufacturers need to conduct clinical trials to show their products work as intended.

    Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world's fifth-biggest selling medicine in 2014 with sales of nearly $9 billion.

    Amgen, which sells the drug in North America, booked Enbrel sales of $4.7 billion last year. Pfizer (PFE.N) sells Enbrel elsewhere.

    Merck (MRK.N) and Samsung Bioepis last month won approval for biosimilar etanercept in South Korea and a copy is also on the way in Europe, where Samsung [SAGR.UL] is working with Biogen (BIIB.O), but Sandoz said it believed it was the first company to receive a U.S. FDA file acceptance.

    Sandoz is seeking approval for all indications included in the label for Enbrel, a so-called anti-TNF drug, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis, it said in a statement.


    Novartis last month launched the first biosimilar drug in the United States after a U.S. appeals court declined to stop the sale of the company's copycat version of Amgen's blockbuster cancer drug Neupogen.

    Insurers and government healthcare systems hope biosimilars will cost the public 40 percent to 50 percent less than the original drugs and experience in Europe suggests that steep discounts are being offered in some markets.

    "Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is essentially the same as the reference product," Novartis said on Friday.
    Amgen, which sells the drug in North America, booked Enbrel sales of $4.7 billion last year. Pfizer (PFE.N) sells Enbrel elsewhere.

    Merck (MRK.N) and Samsung Bioepis last month won approval for biosimilar etanercept in South Korea and a copy is also on the way in Europe, where Samsung [SAGR.UL] is working with Biogen (BIIB.O), but Sandoz said it believed it was the first company to receive a U.S. FDA file acceptance.

    Sandoz is seeking approval for all indications included in the label for Enbrel, a so-called anti-TNF drug, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis, it said in a statement.

    Novartis last month launched the first biosimilar drug in the United States after a U.S. appeals court declined to stop the sale of the company's copycat version of Amgen's blockbuster cancer drug Neupogen.

    Insurers and government healthcare systems hope biosimilars will cost the public 40 percent to 50 percent less than the original drugs and experience in Europe suggests that steep discounts are being offered in some markets.

    "Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is essentially the same as the reference product," Novartis said on Friday.
     

  2. we cant decide if we love biosimilars or hate biosmilars

    oh well... there goes enbrel.....
     
  3. anonymous

    anonymous Guest

    We will see if NVS can get passed a composition of matter patent issued for Enbrel in 2011 that expires in 2028. These are the most difficult patents to invalidate. Let's see how Amgen legal handles this. I would expect a very vigorous defense of this and other Enbrel patents. They may have got Zarxio approved as a Neupogen biosimilar but I don't expect a similar path here.
     
  4. anonymous

    anonymous Guest


    Biosimilar development aint cheap. Novartis isn't dumb and they won't go after this patent if it wasn't unreasonably indefensible. If there is biosim Humira and Enbrel, this shit is gonna hit the fan fast.
     
  5. anonymous

    anonymous Guest

    INBU is screwed. Enbrel losing share day by day. No brodalumab. AMG 416 for neph is the only redeeming product but neph isn't going to be big. Amgen needs to get rid of inflammation.
     
  6. anonymous

    anonymous Guest

    cso for inbu coming soon
     
  7. anonymous

    anonymous Guest

    There will be multiple adalimumab biosimilars come January of 2017. No need to worry about an etanercept biosimilar. Adalimumab is a better TNF all-round in RA, PsO, PSA and IBD vs. etanercept. The adalimumab biosimilars will take out Enbrel on its own. Good-bye INBU.
     
  8. anonymous

    anonymous Guest

    We are the better RA TNF!
     
  9. anonymous

    anonymous Guest

    They are about the same. In derm, enbrel gets killed.
     
  10. anonymous

    anonymous Guest

    Get real. Both are the essentially same in mind of the Rheum and Derm today. They write what is paid for by the patient's insurance/PBM. Payers will decide what is used - biosimilar adalimumab at 40-50% savings or Enbrel. Which one do you think they will choose?
     
  11. anonymous

    anonymous Guest


    Mr. Doctors will choose Enbrel because they love me! You must be fat and ugly.
     
  12. anonymous

    anonymous Guest

    Who gonna win dis patent war? Novartis or SCAMgen? Novartis is bigger and have more money. Hillary will make law to screw Amgen. She no like bobby bradway.


    But the path to challenging Enbrel in the U.S. is likely to be more complicated. In 2011, Amgen secured new patents related to the antibody that it says will protect the treatment from biosimilar competition through 2029. Novartis, however, is undeterred in its effort to unseat an injection first approved in 1998.


    "Sandoz believes that it has a good faith legal basis to challenge the validity of these patents," the company said in a statement.
    "If Sandoz is unsuccessful in its patent challenge, and the 2028 and 2029 patents are upheld, patients in the U.S. will not have access to a more affordable version of this product until long after it has become available for patients in other countries."
     
  13. anonymous

    anonymous Guest

    Biosimilar Enbrel and Humira will means bye bye INBU! I better try to get on the CV team. When will Amgen put INBU reps in oncology to replace the Onyx reps that left?