EMA Prepares For Biosimilar Reference Data From Non-EU Sources; U.S. Input Vital
This article was originally published in The Pink Sheet Daily
Executive Summary
The EMA is preparing to accept data from non-EU sourced reference products for biosimilars, but suggests U.S. co-operation is essential to boost global development.
You may also be interested in...
Biosimilars: FDA, EMA Developing Common Data Package Guidance
Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.
FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics
The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.