The FDA approved a record-breaking 46 novel drugs in 2017. Our latest infographic breaks down the FDA's approval history for the last decase.
The FDA approved a record-breaking 46 novel drugs in 2017. Our latest infographic breaks down the FDA's approval history for the last decase.
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.
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.
Regulatory Updates From Around the Globe Provide Hope for Biosimilars
September 9th 2023An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.
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