While Pfizer ($PFE) was reporting a 71% drop in U.S. Lipitor sales and plotting its next spin-off move, Abbott Laboratories ($ABT) was working to shore up its own breakup plans by protecting its pharma unit's lead drug. The Chicago-based company petitioned FDA to stop biosimilar versions of Humira, its lead drug, on trade-secret grounds.
As Pharmalot reports, Abbott claims that, to approve biosimilars, the agency would have to use trade secrets divulged in its Humira approval applications. So, Abbott says FDA shouldn't accept any approval applications--indeed, take "any action" related to a biosimilar application--that cite its own Humira app.
Abbott points out in its petition that courts have confirmed that data submitted to FDA are considered trade secrets. And it contends that biologics applications submitted to FDA before the initial biosimilars legislation was approved--in 2009--all contain trade secrets that are similarly protected.
If that's the case, then we can forget about biosimilars for years to come. As interpreted by Abbott, companies would be limited to knocking off biologics filed for FDA approval after that 2009 legislation was enacted. The biggies now in testing--biosimilar versions of Epogen, Remicade, Herceptin, et al--would be moot. But recent citizen petitions haven't gained much traction at FDA; in fact, a trade-secrets argument failed for AstraZeneca. Will FDA will have more sympathy for Abbott's filing? Color us skeptical. But then, government agencies have done stranger things.
- read the Pharmalot piece in Forbes