The Biologics Price Competition and Innovation Act of 2009 created an abbreviated pathway for biological products to be biosimilar or interchangeable with an FDA-licensed product in the US.  The BPCI Act and subsequent guidance from both the FDA and EU regulatory authorities has catalyzed a surge in the development of biosimilars, as well as the first biosimilar submissions to the FDA in 2014.  A key component to any submission is the extent to which physicochemical and biological (non-clinical) data will be used to support these submissions.<br/>This paper will describe the challenges in obtaining sufficient data to assure characterization of both the brand product and the biosimilar being developed and how these data can be used to optimize manufacture of a biosimilar.  The choice of a broad set of analytics, both physicochemical and biological, as well as the complementary and orthogonal nature of those analytics will be described.   Key characteristics that define both the brand product and the biosimilar will be discussed and will include different approaches to establish equivalence criteria as well as statistical methods which may be used to evaluate the data.  The challenges such as the diversity of the brand product as well as changes over time which can complicate assessment of “biosimilarity” will also be addressed.

Challenges and approaches in demonstrating biosimilarity at the physicochemical and biological level

249th National Meeting (2015)

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