The Top Biosimilars News for the Week of July 16, 2018

Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.

On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.

Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.

On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

The legal and common uses of “interchangeability” continue to be conflated.

Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).