Representative Henry Waxman (D-CA) announced plans to introduce legislation that would establish an FDA approval process for generic biologics.  He announced his plans in a speech to the Generic Pharmaceutical Association (GPhA) yesterday. Rep. Waxman stated, “I intend to introduce legislation that will establish a clear pathway for generic biologics very shortly.”  Moreover, the pathway…

The FDA recently appealed the district court case that forced it to make a decision on Sandoz’s drug application for Omnitrope, which later led to FDA to approve Omnitrope.  Sandoz has called Omnitrope the first ever biogeneric drug. In a decision on April 10, the U.S. District Court for the District of Columbia held, on…

Last Tuesday, on the same day the FDA approved Sandoz's application for Omnitrope, a recombinant human growth hormone (rhGH) that Sandoz is calling the first-ever "biogeneric" drug, the FDA also released a 53-page response to a series of citizen petitions that had opposed FDA approval of Omnitrope.  Consistent with its approval of Sandoz's Omnitrope application,…

Sandoz announced Wednesday that the FDA has approved Omnitrope, Sandoz’s recombinant human growth hormone drug product.  According to Sandoz’s press release, the FDA approval is “precedent-setting” because Omnitrope is the first “follow-on version of a previously approved recombinant biotechnology drug” (or “biogeneric”).  Omnitrope is similar to Pfizer’s Genotropin. The FDA, however, disputes Sandoz’s claim.  According…