The FDA approved Sandoz’s Omnitrope, a follow-on version of an approved recombinant biotechnology drug.
Omnitrope (somatropin [rDNA origin]) was cleared for treating growth disorders in children and adults. It is also approved in the European Union and Australia.
The product is similar to Pfizer’s Genotropin, Sandoz said, and Pfizer fought against its approval.
Sandoz Chief Executive Andreas Rummelt said the company will aggressively market Omnitrope to doctors and will price it about 25% below Genotropin, The Wall Street Journal reported.
Omnitrope’s approval came nearly three years after Sandoz, a unit of
Novartis, filed an application with the FDA. In August 2004, the agency completed its review but said it was unable to reach a final decision because of uncertainty about scientific and legal issues relating to follow-on protein products and that it would have to address the approval through a public process.
Sandoz filed suit against the FDA last September, and in April a federal judge in Washington, D.C., ordered the FDA to make a decision.
In conjunction with last Tuesday’s approval, the FDA issued a response saying its Omnitrope approval does not raise any of the legal, regulatory or scientific issues raised in public comments.
Yet the FDA cautioned that its decision on Omnitrope does not create a new pathway for follow-on versions of all protein products and that new legislation would be needed for that to happen. Still, the FDA rejected petitions from Pfizer and others to turn down Omnitrope.
Certain biologic products, like human growth hormone and insulin, don’t require a change in the law.
Sandoz said it can use the same pathway used for Omnitrope to file some of the other follow-on biotech drugs it is developing.
Such products differ from generics in that they are not rated as therapeutically equivalent to any of the other approved products in their class. They can, however, rely for approval on existing animal studies and human clinical trials about the safety and effectiveness of the approved proteins.
In a statement, Sandoz called the approval a “breakthrough” and said follow-on versions of future off-patent recombinant biotechnology medicines are expected to play a key role in its growth strategy.