New FDA Guidance Would Deny Doctors Information They Need In Prescribing Biosimilar Medicines

The Food and Drug Administration appears to believe it knows better than physicians do what information they need to best treat their patients.

That is the logical conclusion drawn from draft guidance the agency recently released on what should and should not be included on the labels of the latest generation of pharmaceuticals—a new form of biologic medicines called biosimilars.

Biologics are complex large-molecule proteins created from living organisms.  They function within the body’s own biological processes to treat cancer, diabetes, rheumatoid arthritis, and other diseases.  The latest class of the biological medicines are called biosimilars.  They are reverse-engineered proteins with unique manufacturing recipes and are developed to mimic in patients the effect of the original biologic.

However, the physical attributes of the biosimilar drug will never be exactly the same as of the original biologic.  Each biologic drug has its own unique biochemical signature, and this diversity can potentially impact effectiveness and side effects for patients.

Doctors need to know as much as they can about these differences to make decisions about what version will be most appropriate for their patients.

But the FDA thinks that information will confuse doctors.  It has issued draft guidance for biosimilar labeling that excludes from the label the safety and efficacy data that companies gather through the comparative clinical trials they are required by the FDA to perform.

Basically, the FDA is proposing that manufacturers label biosimilars as if they were chemical generic drugs. The active ingredients in generic small molecule chemical drugs are exact duplicates of the brand-name drug they are copying.  Not so with biologics, which are similar but could never be identical because they are created from living organisms.

It is especially odd that the FDA would take this approach to labeling because it earlier argued that it needed a new statutory framework to approve biosimilar drugs because they didn’t fit within its authority to approve generic copies of chemical drugs.  As a result, Congress passed the Biologics Price Competition and Innovation Act to grant the agency a legal and scientific framework to approve drugs in this new class of biosimilars.

But now the agency is saying that it will treat the labeling for biosimilars basically the same as generic drugs.

Why?  Regulators are trying to make decisions easier for physicians, apparently.

The labeling of any prescription drug communicates the product’s safety and effectiveness information to health care providers. The label summarizes the key scientific information that physicians need to assess a medicine’s risk-to-benefit profile and to decide if the product is appropriate for a particular patient.

In particular, the FDA doesn’t want manufacturers to include in the label information about how one version of a biosimilar compares to the original biologic.  However, that “comparative clinical data” could be very valuable to a physician in assessing whether there are any major risk factors in terms of hypersensitivity or other reactions they should know about before administering the drug.

The prescribing information on the label should clearly state that the product is a biosimilar and whether or not it is interchangeable with the original biologic, including safety and comparative effectiveness data.

Not including this information on the label—information gained from tens of millions of dollars in spending on clinical trials—means doctors will not be presented with information that could be crucial in deciding which version of a biosimilar or the original drug would be most effective for their patients at the point of care.  This creates a risk that doctors would see products that are in fact not interchangeable can be treated the same.

The FDA’s response:  “Due to the potential for differences in clinical study parameters, we think that including comparative clinical data in biosimilar product labeling would be confusing or even potentially misleading to health care providers,” writes Leah Christl, Ph.D., Associate Director for Therapeutic Biologics and lead of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs.

The newest class of biosimilar drugs holds tremendous promise, both in their therapeutic potential and in bringing more affordable versions of medicines to patients who need them.  But withholding necessary information from physicians because it could be “confusing” or “potentially misleading” is demeaning to medical professionals and could lead to mistakes and unknowing misuses of specific drugs that will undermine trust in these new medicines.

More, not less, transparency is needed so physicians have data that will facilitate the best medical decisions for their patients. Physicians, not regulators, know best.

Read the article in Forbes


About the author

Grace-Marie Turner is president of the Galen Institute, a public policy research organization that she founded in 1995 to promote an informed debate over free-market ideas for health reform.

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