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Why few biosimilar companies may use FDA’s proposed interchangeability pathway

FDA’s draft guidance on demonstrating interchangeability with a reference product cracks open a door into a generics-like marketplace but, in many settings, manufacturers may decide it isn’t worth the expense.

The guidance sets a high scientific and technical bar for interchangeability designation that some companies may not be able to reach. Especially for highly complex biologics, FDA may require more precise analytical characterization than is needed to obtain approval as a biosimilar. For any biologic that is likely to be administered more than once, the agency will require studies to demonstrate that switching a patient back and forth between a proposed interchangeable and a reference biologic is safe and doesn’t alter efficacy.

Interchangeability will be most attractive for self-administered biologics used for chronic conditions, such as immunology drugs that may be eligible for automatic substitution by pharmacists.

Unless payers or physicians associate interchangeability with higher quality or safety, the interchangeability designation might not be valuable for drugs dispensed in hospitals and physicians’ offices, where decisions by group purchasing organizations or PBMs and formulary committees will determine which biologics patients receive.

Economic factors will also influence decisions about seeking interchangeability. It might be more rewarding to establish market share quickly with a biosimilar than to obtain an interchangeability designation.

“They chose to keep the bar high by relying on the stepwise approach developed for biosimilarity.”

Bruce Leicher, Momenta


Draft guidance documents are always subject to change before they are finalized, and there is even more than the usual level of uncertainty about the final fate of the interchangeability guidance because it was released during the Obama administration’s last week. It may be subject to a regulatory freeze imposed by the Trump administration, or to revision based on the next FDA commissioner’s views.

Clinically doable

The Biologics Price Competition and Innovation Act of 2009 (BPCI), which was included in the

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