ABSTRACT
A historic snapshot points out that the Biologics Control Act was passed in 1902 to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans, years before Congress passed the original Food and Drugs Act on June 30, 1906. Biosimilarity is a description that a sponsor candidate product is indeed biosimilar. This is the final judgmental call by the Food and Drug Administration (FDA), not by the sponsor, and it is based on the FDA, not the sponsor, to conclude that critical quality attributes are highly similar. The sponsor can only label its submission as similar, and not claim it to be highly similar. Clinical trials in patients are different from the trials conducted for new molecules. The focus in conducting patient trials of biosimilars is intended to demonstrate equivalent effectiveness and safety.
