A Biosimilar Must Say It's A Biosimilar: PhRMA/BIO
This article was originally published in Scrip
Executive Summary
To ensure prescribers and patients are informed a product is a biosimilar and not a brand-name biologic, and to protect against any inadvertent substitution of the two, the labeling for the copycat medicines should clearly state they are indeed, biosimilars, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) said in a new petition to the FDA.