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On January 7th 2015, the first product submitted under the new 351K procedure for biosimilars, Sandoz's version of Neupogen (code named EP2006), was unanimously backed by the FDA Oncologic Drugs Advisory Committee (ODAC). The majority of biosimilars currently being developed, however, are orders of magnitude more complex. To what extent lessons from the recent ODAC meeting are relevant to other development programs is a critical insight for any biosimilar developer:
Totality-of-the-Evidence: The analytical and non-clinical similarity exercise will be key to determining the extent of clinical data required to conclude biosimilarity. If minimal residual uncertainty remains, the need for clinical data in patients will be limited or potentially even eliminated.
Tiering of Critical Quality Attributes: Sandoz and the FDA agreed on a four-tier critical quality attribute (CQA) classification system spanning very high to very low in terms of potential clinical impact of the attribute. While this is relatively simple to do for a mono-functional protein such as filgrastim, it becomes far more complex for a monoclonal antibody which possesses both target and Fc functionalities. The applicant for a monoclonal biosimilar will need to understand the structure-function relationship in great detail.
Recognizing the Importance of Structural and Biological Data: Despite the FDA emphasizing the importance of the totality-of-the-evidence, the focus of the ODAC fell heavily upon clinical data. Even the 80-125% equivalence margin for bioavailability, well accepted for generics, was questioned. The relevance of structural and biological data will need to be robustly presented with clarity to counter any unrealistic expectations for clinical evidence.
Market Access: There is significant pricing and market access uncertainty associated with successfully commercializing a biosimilar in the US. Understanding how US payers will respond to the introduction of biosimilars, determining what price can be achieved, what restrictions will be imposed, and what payers will require from companies bringing biosimilars to market will be crucial.
I have touched on some relevant implications and look forward to discussion on this topic going forward.
Japan is the second largest pharmaceutical market and success in Japan is mandatory for pharmaceutical companies.…
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