Approval pathway for biosimilars still evolving

August 15, 2011

It's complicated. Those words sum up the current status and apparent future of biosimilars.

Key Points

It's complicated. Those words sum up the current status and apparent future of biosimilars, which received a boost from the Patient Protection and Affordable Care Act and its amendment of the Public Health Service Act of 2009.

In brief, the legislation establishes:

The path to biosimilar approval

Incomplete agreement and layers of complexity

"Right now, legislation is high level, but it should become more specific regarding requirements by the end of the year. There is not complete agreement on what biologics are, and now we are adding another layer of complexity with biosimilars," Sherman said.

Without a standard definition of a biologic, Sherman said, products with biological components may be approved through either drug or biologic licensure pathways.

For example, the FDA approved an abbreviated new drug application (ANDA) for generic enoxaparin (low-molecular-weight heparin) in 2010, while the European Medicines Agency (EMA) considers low-molecular-weight heparins to be biologics and requires a more robust approval.

Another concern is just how much research will be necessary to establish similarity, since a biosimilar is not an exact replica of an innovator product.