Colombian decree will allow 'non-comparable' biologics, say R&D firms
This article was originally published in Scrip
Executive Summary
The publication of a Colombian decree on the evaluation of biotechnological medicines has caused something of a stir, not least because it offers three separate approval pathways, one of which R&D-based companies say will allow the approval of "non-comparable" versions of originator biologic medicines.
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.