Smart biosimilars approval pathway key for patient safety


by Earlexia M. Norwood, MD

The Department of Health and Human Services (HHS) is second only to the Department of Defense in its total budget, but first in the Federal government in terms of its influence on most American’s daily lives.

The most important agency within HHS is the Food and Drug Administration (FDA), which protects our food supply and keeps tabs on new pharmaceuticals to ensure they are both safe and effective. This includes generic drugs, which, like innovator drugs, must be approved by the FDA before their legal sale to patients.

Until recently, the process of getting a generic drug approved has been relatively simple for manufacturers, because traditional chemical drugs are easily duplicated. But a new class of drugs called biologics is now being developed, not by manipulating chemicals, but by manipulating genes.  The discovery, manufacture, and testing processes for biologics are much more complex than those associated with the creation of traditional chemical drugs, as is the process to duplicate them. In fact, it is impossible to exactly copy a biologic innovator drug.

Instead we have “biosimilars,” which—as their name suggests—are similar, but not exact versions of biologics. But in medicine, minor changes can have major effects which can endanger patients.

The FDA recognizes this potential danger, recently stating that biological products can “pose scientific and technical challenges associated with the larger molecular structure and manufacturing of biological products.”  The agency is currently looking into the specific issues and challenges associated with establishing a safe biosimilars approval process, as was directed by the health care reform law.

The FDA should build on the European Union’s (EU) approval pathway model. Thanks to their system’s requirement for mandatory clinical testing, European patients have been effectively protected from harm caused by unknown biosimilar drugs.

Hopefully the FDA will take lessons from the EU’s biosimilars approval, because time is of the essence, and when it comes to patient safety, failure is not an option.

Earlexia M. Norwood family physician at Henry Ford Medical Center.

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