12.10.20 -- Why Severability Should Be In Your Biosimilar Vocabulary

In the upcoming months, the Supreme Court will (hopefully) be deciding whether Congress intended for the entire ACA to survive should individual provisions be found unconstitutional. So, for better or worse, the biosimilar industry has a few more months of pondering the (excruciating) “what ifs” around the future of the BPCIA. 

This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product along the regulatory timeline.

The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.