FDA approves first follow-on biologic ...

FDA has granted approval for the first follow-on recombinant protein drug in the U.S. Sandoz, the generic drugs arm of Swiss pharmaceutical giant Novartis, has received the green light to launch Omnitrope, a recombinant human growth hormone for treating growth disorders in children and adults. The drug is similar to Pfizer's Genotropin and Serono's Saizen. In its comments about the approval, the agency calls Omnitrope a relatively simple protein that could be compared with approved growth hormones. Furthermore, FDA says its decision does not clear a path for the approval of biosimilar versions of recombinant proteins or more complex protein drugs. European regulatory authorities approved Omnitrope in April.