Skylar Jeremias


Biosimilars Regulatory Roundup for November 2022—Podcast Edition

December 04, 2022

On 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.

Biosimilar Regulatory Roundup: November 2022

December 01, 2022

In November, several global agencies progressed insulin biosimilars, the European Union approved another ranibizumab biosimilar, and a US Senate bill to rid switching study requirements for interchangeability was introduced to Congress.

Biosimilar Business Recap: Progress for Insulin in Europe, Canada; Biocon Biologics' Viatris Acquisition Completed

November 30, 2022

Capstone has announced that its human insulin biosimilar received positive opinions from the European Medicines Agency and Health Canada, signaling approvals may be on the horizon, and the acquisition of Viatris’ biosimilars portfolio by Biocon Biologics is officially complete.

Amneal, Kashiv Launch Filgrastim Biosimilar, Releuko

November 29, 2022

After receiving FDA approval in February 2022, Amneal Pharmaeuticals and Kashiv Biosciences launched Releuko (filgrastim-ayow) on the US market, making it the fourth biosimilar referencing Neupogen to be commercially available to Americans.

Regence: Biosimilar Adoption Leads to $37 Million Reduction in Annual Spending

November 28, 2022

Regence found that implementing strategies to increase its biosimilar adoption rate reduced spending on specialty drugs by $37 million annually. The organization is the latest example of how biosimilar use has contributed to significant savings.

What Amgen’s Biosimilar Trends Report Says About the Future of Biosimilars

November 27, 2022

Chad Pettit, the executive director of marketing and global biosimilars commercial lead at Amgen, discusses the most recent version of Amgen's Biosimilar Trends Report and what the report says about the current biosimilar market and how it could develop in the years to come.