Snapshot

The Biosimilar Regulatory Review and Approval pathway has been developed by the of United States.

This pathway can be used where Biological products are the fastest-growing class of therapeutic products in the United States and account for a substantial and increasing portion of health care costs. Congress, through the Biologics Price Competition and Innovation Act 2009, created an abbreviated approval pathway to provide the public with greater access to safe and effective biological products. This pathway provides more treatment options, potentially lowering health care costs through competition and increasing access to lifesaving medications. The abbreviated licensure pathway does not mean that a lower approval standard is applied to biosimilar or interchangeable products. In fact, the data package required for approval of a biosimilar or interchangeable product is extensive. If a biosimilar manufacturer can demonstrate that its product is biosimilar to the reference product, then it is scientifically justified to rely on certain existing scientific knowledge about the safety and effectiveness of the reference product to support approval. This allows for a potentially shorter and less costly drug development program for a biosimilar..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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