FDA’s Biosimilar Interchangeability Guidance Needs Work, Commenters Say


FDA is delving into comments on its draft guidance on interchangeability of biosimilars that are sometimes passionate, occasionally very technical, and often disagree with one another.

The comments from biosimilar applicants, biologic developers, associations, researchers and patient and consumer interest groups are important because the Food and Drug Administration’s ultimate biosimilar interchangeability guidance will provide recommendations to biosimilar applicants on how to show the agency the biosimilar can be substituted for the original biologic without a physician’s approval.

Biosimilars are highly similar versions of FDA-approved biologics that are expected to be 15 to 30 percent less expensive than the original biologics, comparable to generics of chemically based drugs. The biosimilar statute provides an abbreviated approval process for biosimilars and also for the agency to designate a biosimilar as interchangeable after providing the FDA with additional data.

In my article on the comments on the FDA’s draft interchangeability guidance, I wrote that some disagreed whether the standard for approving biosimilarity and interchangeability should be the same or if a higher standard is needed for interchangeability. Some disagreed with the FDA’s preference for using U.S. products in the studies required to show that the patient can switch from the original biologic to the biosimilar safely and with no loss of efficacy. Almost everyone complained that the draft guidance didn’t discuss the labeling and naming of interchangeable biosimilars.

The AARP wrote there is no scientifically justifiable reason for non-U.S. products to be acceptable for biosimilar approval but not for an interchangeability designation, while Johnson & Johnson noted that some differences between biosimilars from various countries can be significant. Premiere Inc. and nine other health-care groups made their concerns clear in their comments: “Requiring switching studies to rely on more expensive, U.S.-licensed reference product samples over less costly samples from other markets, without any real clinical difference between the two will simply create additional, unnecessary barriers to entry for biosimilar developers.”

The FDA’s job is to sort it all out. Stacie Ropka, a partner at Axinn, Veltrop & Harkrider LLP in Hartford, Conn., told me she believes the FDA will proceed toward a final guidance “in a manner to ensure interchangeable biosimilar products get to the marketplace promptly but in a way that doesn’t compromise safety. In other words, in the same way the agency finalized its guidance on biosimilarity.” When it does, Bloomberg BNA will report on the final interchangeability guidance and its impact.

You can read my full article here and access all the comments here.

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