Biosimilar warfare in US: Abbott's Humira is under attack
This article was originally published in SRA
Executive Summary
Interest in biosimilar development in the US is growing despite the continuing uncertainty over a number of regulatory issues, including whether or not the March 2010 legislation implementing a biosimilars pathway is retroactive or not1,2.
You may also be interested in...
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.