Up until last month, the Food and Drug Administration (FDA) has wavered on how it will regulate copycat drugs. Now, the FDA has made it more clear how it plans to define biosimilarity of copycat drugs being reviewed and the approved drugs they are trying to replace. In providing preliminary guidance, the FDA identified the following four categories of possible similarity between an established drug and its copy:

  • Highly similar with fingerprint-like similarity: Copycat drug meets a highly-sensitive, statutory standard for similarity
  • Highly similar: Copycat drug meets the statutory standard for similarity
  • Similar: Copycat drug requires more studies to see whether changes in manufacturing help to show similarity
  • Not similar: Copycat drug does not measure up to the original

In a best-case scenario, developers of biosimilars would only need to perform targeted animal or human studies to demonstrate their drugs match the original ones. The knockoff drugs that are dissimilar to the original drugs would not receive further consideration unless changes are made to their manufacturing processes.

While the FDA continues to clarify its treatment of biosimilars, the anticipated billion-dollar market for these biosimilars continues to be in a “hurry up and wait” mode. Because of this potential market, a number of producers of established drugs (e.g., Amgen and Biogen Idec) have gone on offense by beginning to invest in the manufacturing of their own biosimilars.

In order to read the FDA’s draft guidance, click here: FDA Draft Guidance


Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti