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GHLF Submits Letter to FDA Requesting Distinguishable Names for Biosimilars

On September 26th GHLF submitted a letter to Commissioner Hamburg at the FDA written by GHLF Chief Medical Officer, Dr. Jonathan Krant.  The letter explains that biosimilars are not like generic drugs. A biosimilar product is highly similar to, but not the same as it’s reference biologic product. Therefore, from a patient safety perspective, it is not appropriate to allow the same name to be used for biologic products that are in fact not the same.

In the letter, from his perspective as a prescribing physician, Dr. Krant states that a system of unique, distinguishable names are needed to ensure timely detection, assessment, and prevention of any adverse effects from a product. GHLF believes it is pivotal that each biologic medicine have a distinguishable non-proprietary name.

Click here to read the full letter.