This blog post follows up on an article in the Washington Post about the long road that lies ahead for companies hoping to gain approval for biogenerics. The article follows Insmed's CEO, Geoffrey Allan, who has been advising Congress on drug pharmacology in order to speed up the approval process. "However, the applicant must provide evidence that its product will produce the same clinical result as the brand product in any given patient and that it presents no additional safety risks or diminished efficacy if a patient alternates or is switched between products. This will be a tough road to travel," says a post at Patent Baristas.
Teaching Congress a Thing (or Ten)
Aug 15, 2008