The EMEA's Committee for Medicinal Products for Human Use has given its second recommendation for an approval of a biosimilar therapy. Committee members recommended EMEA approval for BioPartners' growth-hormone Valtropin, which is a generic version of Merck's Humatrope. The Committee recently approved Omnitrope, another biosimilar growth hormone.
The European regulatory action is likely to put continued pressure on the FDA to begin addressing calls for approving biosimilars in the U.S. Biotech companies have been steadfastly opposing the idea, saying that biotech drugs are too complex to allow knockoffs. Critics say they just want to avoid the cut-rate competition. Growth hormones have been around for some time now, though, and it's unlikely that the FDA will be able to resist advancing biosimilars if the process works in Europe.
- here's the release