Monday, July 2, 2012

Biosimilar Development and the Affordable Care Act: What Next?

On June 28, 2012 the Supreme Court upheld the Affordable Care Act (ACA) in a vote of 5/4 in favor of taxation for individual health care costs.  The original bill required Americans to obtain health insurance or face penalties.  The ACA was signed by President Obama in March 2010 and was immediately challenged by twenty-six states, individuals and the National Federation of Independent Business in Federal District Court to challenge the individual mandate. Included in the ACA, was the Biologics Price Competition and Innovation (BPCI) Act that authorizes an abbreviated pathway for the development of biosimilars of FDA-approved biologic reference products.  Basically, biosimilars are versions of biologic drugs that have been shown to have similar safety, purity, and efficacy as the FDA approved product.  The biologics market is estimated to be worth over 100 billion dollars worldwide.

Since biologics therapies are expensive, biosimilars will be a relief to the US healthcare system offering a 30-40% decrease in cost. In an effort to minimise profit loss of their own lucrative biologics therapies, several multinational drug firms have partnered with successful small molecule generics manufacturers to develop biosimilars.  Companies such as Merck are partnering with Dr. Reddy, Amgen has partnered with Watson Pharmaceuticals, and surprisingly the technology company Samsung partnered with biotech giant Biogen Idec.  These multi-billion dollar partnerships signal a new era in therapeutic development.  It appears that the biosimilars business model, at least for now, is “ If you can’t beat them, join them”. 

For companies that want to learn more about the strategic frameworks necessary to optimize success in this rising therapeutic area make sure to attend the 13th Annual Business of Biolsimilars and Generic Drugs meeting held at the Hilton Boston Back Bay in Boston, MA September 10-12, 2012.  Companies can plan on gaining invaluable insight into partnering, global biosimilar development and approval.  Here are a few of the key presentations: Stanley Hong, SVP,Celltrion presenting The Strategy and Case Study of Global Biosimilar DevelopmentSuzanne Sensabaugh, CEO, HARTMANN WILLNER, LLC presenting Adapt to New Regulatory Requirements for Biosimilar Approval and Success and Brian Harvey, Vice President, U.S. Regulatory Strategy, PFIZER and Carrie Burke, Director of Government Affairs, SHIRE presenting Outlook and Strategic Impact of U.S. Bosimilar Approval Pathway.  For more information on these sessions and the rest of the program, download the agenda.  If you'd like to join me in Boston for the Business of Biosimilars and Generic Drugs, register today and mention code XP1786BLOG and save 25% off the standard rate!

So, what hurdles do you foresee for biosimilar manufacturers? Do you think biosimilars will live up to the hype and offer the 30-40% savings over innovator therapies that analysts are predicting? How long do you think it will take for biosimilars to enter the US market? Do you think physicians and patients will accept these new therapies?


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2 comments :

BioPharma99 said...

Potentially, this market could be the
single fastest-growing biologics sector in the
next few years. This would most likely be brought on by the convergence of dynamics
that would see new biosimilars enter the US market
by 2014.

Amy Belton said...

Yes, I would agree. With the imminent release of the FDA biosimilar guidelines and the recent release of India's guidelines there is enormous potential for a global market boom!

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