The National Kidney Foundation is celebrating a victory today after the FDA published (.pdf) a proposal to make it easier to identify biologic drugs by adding a four-letter suffix to the non-proprietary (generic) name. Making a “generic” version (biosimilar) of a biologic drug is more complex than a typical generic drug. What does this mean for patients? Even small changes in the manufacturing process can potentially lead to side effects in some patients not found with the original biologic drug. It is therefore important to patient safety to make sure that clinicians, pharmacists and patients can easily determine which biosimilar is being used. The assigning of a unique name to each biosimilar will aide in this awareness.
In 2013, NKF advocated (.pdf) for assigning of a unique ID to each biosimilar.Without the unique name it is possible that the reporting of side effects will be tied to the wrong product, either the biologic or the biosimilar, which could lead to a delay in detecting a more widespread problem. NKF is confident that biosimilars approved by the FDA are just as safe as the original biologic, but having a unique name for each biologic will help in timely and accurate reporting of any adverse side effects.
While it is uncommon that any biologic drug would pose a serious health threat to patients after it had been approved by the FDA, there have been two instances where this has occurred with biologics used in kidney patients. A decade ago the Food and Drug Administration collected information on 82 patients worldwide who had developed pure red-cell aplasia as a result of changes in the manufacture and/or packaging of a reference biological product used by kidney patients. More recently a synthetic erythropoietin stimulating agent, peginesatide, was approved by the FDA in March of 2012 and nearly a year later pulled from the market.
Given this experience, NKF supports an easy way for patients and prescribers to distinguish between original biologic drugs and their biosimilars. The National Kidney Foundation is supportive of the introduction of biosimilars to the market as a potentially lower cost and clinically effective option for patients, many who currently struggle to afford their medications. However, patients have the right to know the exact product they have received and physicians also need this information in order for both parties to properly report any adverse events to the FDA. This naming proposal by the FDA is a positive step and the National Kidney Foundation hopes the FDA will approve this measure.