Omnitrope (somatropin) Approved by FDA
Well, it happened a bit later than I had originally predicted (I predicted in early 2005 that approval would occur in late 2005), but probably sooner than it would have happened if Sandoz hadn’t sued FDA. I’m speaking, of course, of the U.S. marketing approval of Sandoz’ Omnitrope (recombinant GH). Although FDA has downplayed the approval as not precedent-setting, it is, in fact, controversial and important to the industry, because Pfizer had fought to block it using the argument that Sandoz should not be allowed to reference public data on Genotropin in its NDA. This argument has also been used as a general reason why FDA should not approve “generic biologics” without additional statutory authority. It seems, once again, that FDA has rejected this line of argument, although they are standing firm on the need for additonal statutory authority before labeling a biologic as generically equivalent to a previously approved biologic. Omnitrope did not require such an equivalence rating, because it was approved under 505(b)(2) of FDCA, rather than 505(j). Other biologics (proteins/peptides) that could potentially receive approval via 505(b)(2) pathway include all recombinant insulins, Thyrogen (thyrotropin), Symlin (pramlintide), Somavert (pegvisomant), Natrecor (nesiritide), Iplex and Increlex (IGF-1), Follistim (follitropin beta), GnRH agonists/anatagonists, Calcitonins, etc. Note FDA’s arguments for approving a protein/peptide via 505(b)(2) found in the story’s link. Note also that the Orange book patent covering the 505(b) applicant’s product must have expired before a 505(b)(2) application will be reviewed by FDA.
