EMEA Product-By-Product Biosimilar Guidelines To Continue With Alfa Interferon
This article was originally published in The Pink Sheet Daily
Executive Summary
Additional product-level annexes to European biosimilar guidelines will be created as needed, German regulatory official Weise says.
You may also be interested in...
Valtropin Is The Second Biosimilar Product Approved In Europe
Biopartners’ somatropin is a follow-on to Pfizer’s Genotropin.
Valtropin Is The Second Biosimilar Product Approved In Europe
Biopartners’ somatropin is a follow-on to Pfizer’s Genotropin.
Follow-On Biologics Guidances Will Take A Broad Approach
The plan is a shift from FDA’s previous intention to issue “product-specific” guidances.