Recently, FDA released renaming structure for biosimilar products. While biosimilars behave similarly to original product, they are chemically altered. It is because of this that biosimilars must have a different naming system as to not misinterpret the drugs. The guidance states that the new naming structure will involve a “proper name,” which is shared, followed by a four lowercase letter suffix to specify. According to FDA Voice, this new system will allow safer and more accurate monitoring and tracking of products.
To read Michael Mezher’s full article, click here.