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Regulatory Focus™ > News Articles > Interchangeability: The Next Great Debate on the Biosimilars Landscape?

Interchangeability: The Next Great Debate on the Biosimilars Landscape?

Posted 01 February 2011

With last year's passage of the Patient Protection and Affordable Care Act, which included a legal framework for the approval of biosimilar drugs via the Biologics Price Competition and Innovation Act of 2009, attention has focused on what an approval pathway might look like and the kinds and extent of data necessary to demonstrate equivalence to the innovator product. Under the new healthcare law, a biotech product must be "similar enough" to a reference product to allow reliance on existing information about the chosen reference product. The law authorizes the US Food and Drug Administration (FDA), on a product-by-product basis, to determine the evidentiary standard for approval of a follow-on biologic as biosimilar to a reference biologic. FDA has held a public meeting and consulted with stakeholders on how to implement a regime that ensures the safety and efficacy of follow-on biologics based largely upon reference product data.


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