Pharma’s Cutting Edge

BioPartners failed to impress the CHMP with its biosimilar application for Alpheon, a biosimilar to Roferon A. Had Alpheon been approved, it would have marked the first non-GH biosimilar approval in Europe. This case demsnstrates some of the technical hurdles that must be cleared to receive EU approval. I would expect that similar issues would be raised by FDA for a Roferon-A biosimilar in the U.S. submitted via the 505(b)(2) path. If anything, FDA is likely to be stricter than the CHMP. I’ve followed the biosimilar story closely for the past three years and will continue to keep you updated on its evolution. If your firm sells recombinant products, there is no single issue more likely to change your firm’s long-term prospects than this one.