EMEA Denies Biosimilar To Roche’s Interferon Alfa-2a
This article was originally published in The Pink Sheet Daily
BioPartners’ Alpheon – a generic version of Roferon-A – has “major quality concerns,” the European Medicines Agency finds.
You may also be interested in...
Biopartners’ somatropin is a follow-on to Pfizer’s Genotropin.
Roche will consider requesting a re-examination of the negative decision by the Committee for Medicinal Products for Human Use.
A Phase III trial will compare 40 mg/day glatiramer to the 20 mg/day approved dose.