Fill-Finish & Packaging

(Picture credit: Joe Flintham/flickr)

J&J and EGA differ on safety impact of same INNs for biosimilars

By Fiona Barry

Johnson & Johnson (J&J) has called on the US FDA to prevent biosimilars being given the same non-proprietary names as their original biologics, while the European Generics Association maintains the practice is “proven to be safe” and “supported...

More Manufacturing Issues Lead to Alexion Recall

More Manufacturing Issues Lead to Alexion Recall

By Dan Stanton

Alexion Pharma International has recalled a single lot of its monoclonal antibody (MAb) orphan drug Soliris due to the presence of visible particles in a limited number of vials.