Biosimilar Development and Commericalization

Today's guest post is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.

The global development and commercialization of biosimilars in the US, EU and the world market is closer to becoming a reality. Currently, the US does not have an approved pathway for biosimilar development.  For companies interested in taking advantage of this market it is imperative that they become familiar with the regulatory, developmental, and legal aspects of global biosimilar production in their respective markets.   The global biosimilars market is estimated to be worth  approximately 18 billion dollars by 2017.  This is due to patent expirations on several blockbuster products such as Enbrel ® (Amgen), Epogen® (Amgen), Remicade® (Janssen), and Rituxan® (Biogen Idec). These patent expirations allow for the development of cheaper versions of highly complex and effective therapies.  As a result many countries are drafting guidelines for the development of biosimilars.

The US FDA recently held public hearings with stakeholders to discuss its current version of draft guidances for the development of biosimilars.  The stakeholder community consisted of patient advocacy groups, payer groups, big pharma and biotech companies.  Participants brought up issues pertaining to biosimilarity and interchangeability, reference versus biosimilar naming and labeling, use of reference samples from non-US sources for clinical trials, and the need for specificity as to which analytical methods are required for establishing biosimilarity. Presenters also warned the FDA about the ambiguity of the first drafts of the guidance documents and requested a more detailed final draft of the guidance document.   The final version of the FDA guidances on biosimilars should be finalized soon making it possible fro companies to develop much needed therapies.

The 13^th Annual Business of Biosimilars and Generic Drugs meeting on Sept 10-12, 2012 in Boston, MA will be one of the most informative events for those entering the biosimilars market.   Many of the speakers work with global manufacturers and will address some of the most pressing issues in the market with respect to biosimilar development and commercialization.

In the weeks leading up to the  13^th Annual Business of Biosimilars and Generic Drugs meeting I will discuss topics with global implications to the development of the biosimilars market.  To find out more about this year's agenda, download it here.  If you'd like to join me, as a reader of this blog when you  register and mention code XP1786BLOG, you'll save 25% off the standard rate.

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