The FDA and Commissioner Scott Gottlieb, MD, have made a number of announcements already in 2018. Here are 3 key regulatory developments that have taken place in the early days of January.
The FDA and Commissioner Scott Gottlieb, MD, have made a number of announcements already in 2018. Here are 3 key regulatory developments that have taken place in the early days of January.
Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development
September 13th 2023An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.
Biosimilars Regulatory Roundup for November 2022—Podcast Edition
December 4th 2022On this episode of Not So Different, we recap some of the big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.
The Growth of Biosimilars Continues to Create Hope for Lower Drug Costs
September 7th 2023Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.
Stelara and Enbrel Chosen for IRA Price Negotiation
August 29th 2023Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).
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