Could the fate of biosimilars in the USA rest on the healthcare reform ruling?

US Supreme Court

June 2007 was the first bill leading to the approval of biosimilars to be passed in the United States. Senator Edward Kennedy of Massachusetts first introduced the Biologics Price Competition and Innovation Act.  However, it wasn't until 2010 that the Affordable Care Act gave an actual, legal pathway for biosimilars to be approved in the United States.  With the market on biosimilars growing at such a rapid pace, $112.93 billion in 2011 which was up 4.6% from 2010, there is a severe, cost controlled need from the public.  Many drug companies are seeing this need and forming partnerships to bring biosimilars to the market.  Biosimilars were not specific to the case against the Affordable Care Act presented to the Supreme Court according to Medill Reports in Chicago.  Hospira, who is currently working to bring biosimilars to the market, believe that if the healthcare reform  law is overturned, they believe they can take their biosimilars through the approval process by way of the biologics application. They intend, along with many other companies, to continue the development of this needed treatment whether or not this pathway is overturned.

This fall at the Business of Biosimilars and Generic Drugs Conference, Pfizer and Shire will be on hand to present "Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway," a presentation covering the full spectrum of where biosimialrs are in the process of approval from the government, interchangeability with biologics and more.  For more on this session and the rest of the event, download the brochure.  If you'd like to join us this September in Boston, as a reader of this blog you save 25% off the standard rate when you register and mention code XP1786BLOG.  


Do you think the Supreme Court will overturn the part of the Affordable Care Act and set back the approval process for biosimilars?  What effect would this have on the development process?

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