|
BioPartners remains positive after Alpheon CHMP ruling |
|
|
|
30 Jun 2006 |
Today expressed disappointment that its biosimilar Interferon Alpha, Alpheon®, had received a negative opinion from the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP).
BAAR, Switzerland | Jun 30, 2006 | BioPartners, a privately-owned biopharmaceuticals company today expressed disappointment that its biosimilar Interferon Alpha, Alpheon®, had received a negative opinion from the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP). The ruling was based on questions concerning CMC (Characterization, Manufacturing and Control) and biosimilarity that have not yet been resolved to the extent the CHMP believes necessary for a biosimilar.
BioPartners is looking forward to evaluating the EMEA report and with the issues clarified, anticipates being in an even better position for resubmission. Only a few months ago BioPartners received marketing authorization for the European Union for Valtropin, a further biosimilar medicinal product from BioPartners.
SOURCE: BioPartners |
