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FDA Biosim Interchangeability Guidance is Befuddling

Continuing our deep dive into biosimilars

It may well take the wisdom of Solomon to fully appreciate the logic of the recently released guidance (or non-guidance?) on communicating biosimilar interchangeability. 

The guidance treads a fine line. It says that (many??) prescribers are already picking a biosimilar because it was approved as being the same as the reference product and, therefore, can be ‘considered’ interchangeable…. even if the FDA did not pin the official interchangeable designation medal on its chest.

Only four biosimilars have been Olympic interchangeable medal winners to date. The press release below touches on the fact that this designation is important since many state pharmacy laws / regulations require pharmacist substitution. However, qualifying for FDA interchangeable eligibility requires jumping through several more hoops….. and that translates into time and money. None the less, some biosim manufacturers are pursuing the designation post-launch.

So, the FDA is soft peddling the way interchangeability is communicated. They essentially say that it should not be mentioned in the package insert / prescribing information since the prescriber is free to refer to the Purple Book for that information. That is a good example of the definition of the word ‘befuddling’.

In short, this conundrum is likely to continue for some time.




Key Takeaways:

  • Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance.
  • FDA justified its reversal on including the interchangeability disclosure in labeling by inferring that prescribers pay little heed to interchangeability information in labeling when considering biosimilars for patients.
  • This labeling policy eliminates an important advantage of interchangeability designations and hints at a broader agency trend to minimize the designation’s significance.

The Food and Drug Administration (FDA) released a new Draft Guidance document…..

……….. press release continues

CLICK HERE to read the full press release


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