Forbes: Abbott Petitions FDA To Prevent Humira Biosimilars

In a move that is sure to raise debate about the path forward for biosimilars, Abbott Laboratories has filed a citizen’s petition with the FDA in which the drugmaker asks the agency not to approve any biosimilar for its Humira treatment for rheumatoid arthritis. On what grounds? Abbott argues that the FDA would have no choice but to use trade secrets submitted to the agency when approval for Humira was first sought.

Read More: http://www.forbes.com/sites/edsilverman/2012/04/30/abbott-petitions-fda-to-prevent-humira-biosimilars/

6 Comments
6 comments
  1. RA Guy says:

    Complete madness. First, big biopharma was against the development of biosimilars because of the “health risks” they might present (as if anyone believed that was the primary thing they were concerned about protecting.) Now, they’re against biosimilars because the approval process for any such drugs would violate their trade secrets.

  2. Jennifer Dye Visscher says:

    I wonder how many lawyers it took to come up with this gem? And, how much good that money spent could have done. I understand the need for protecting drugs for a certain length of time – the companies research, test, and spend billions bringing drugs to market. Fine – have your 7 years but Pharma has managed to compete knowing they have that amount of time to not only recoup their costs but factor in big fat profits. Fine. But what makes Abbott so special at this point in time??? Really horrible precedent would be set if they win this.

  3. Joie says:

    Humira’s patent expires in 2016, so they are trying to block competition from a biosimilar, tho the FDA has yet to approve an approval process for biosimilars that the new health law, the Affordable Care Act required.

    Enbrel, a biologic whose patent should expire this year, may have its patent extended 17 more years, the result of an ongoing legal issue that recently got resolved.

    http://www.nytimes.com/2011/11/23/business/amgens-new-enbrel-patent-may-undercut-health-care-plan.html

    75% of prescriptions drugs used in the US are generics. The money to be made by pharmaceutical companies is in expensive drugs like biologics. But how long should they be allowed to profit and drive up costs in our health care system? Enbrel became available in 1999, Humira in 2003 – in 2011, each had $3.5 billion in sales in the US. Haven’t they recouped the cost of R&D already, and more, to be spent on R&D for new drugs – or is it about keeping their shareholders happy?

    http://www.imshealth.com/deployedfiles/ims/Global/Content/Corporate/Press%20Room/Top-Line%20Market%20Data%20&%20Trends/2011%20Top-line%20Market%20Data/Top_Products_by_Sales.pdf

    Biologics have effectively managed RA for many, but as health care costs have risen, and insurance premiums increase, more of health care costs are being shifted to the insuree, the consumer. I pay a reasonable copay now, but how long before my insurer changes to coinsurance for my biologic, with a cost share of 20% or more for a drug that costs nearly $2,000 a month.

    RA is a chronic and lifetime condition, will I be able to afford a biologic in future years? And, for the growing number of uninsured — tens of millions Americans — how could they ever afford a biologic?

  4. Joie says:

    No wonder, Abbott is trying to block a Humira biosimilar……..

    “Abbott’s Humira set to become world’s top-selling drug”

    “Abbott Laboratories’ $9-billion arthritis drug Humira is set to take the crown as the world’s top-selling medicine this year…

    The medicine is expected to retain its market-leading position through 2016, by which time it will rack up sales of $11.75 billion….”

    http://articles.chicagotribune.com/2012-04-11/health/chi-abbotts-humira-set-to-become-worlds-topselling-drug-20120411_1_abbott-s-humira-anti-tnf-drugs-rheumatoid-arthritis

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