In The U.S., Pharmacy-Level Biosimilar Substitution Remains A High Bar

Recent changes in the FDA's biosimilarity assessment guidance do not address the other side of the biosimilar coin, interchangeability. Unique to the U.S., pharmacy-level substitution is allowed only when companies clear an additional regulatory hurdle of receiving an interchangeability designation.

During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, Diana Colleluori, a principal consultant at Biologics Consulting Group, said that, from her perspective, interchangeability remains a formidable obstacle. However, when it comes to the decline of switching studies, once necessary for interchangeability, FDA now puts greater emphasis on multiple functional assays.