Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
Biosimilars Executive Leah Christl Offers Amgen’s Perspective On The Need For Efficacy Trials
Executive Summary
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.
You may also be interested in...
Price Negotiation Purgatory: Upcoming Biosimilars Couldn’t Keep Stelara, NovoLog Off The List
Neither product counts as an ‘extended monopoly’ drug under the Inflation Reduction Act, meaning biosimilar entry cannot prevent Medicare from negotiating its price.
US Bill Takes Another Shot At Biosimilar Interchangeability
Draft legislation reintroduced in the US is seeking to remove the need for switching studies to demonstrate biosimilar interchangeability, making all approved biosimilars automatically interchangeable.
EMA-HMA Biosimilar Interchangeability Statement Offers ‘Unity And Clarity’ For Europe
The recent statement by the EMA and HMA affirming the interchangeability of biologics and biosimilars has given a boost to Europe’s biosimilars industry ahead of key legislative reforms, heard delegates to Medicines for Europe’s 18th Biosimilar Medicines Conference in Brussels.