Abbott Labs wasn’t considered a serious biologics manufacturer when the biosimilars pathway was first being debated. But with the arthritis treatment Humira now the world’s best-selling pharmaceutical brand, the company has assumed a leadership position just as the biosimilar opportunity is emerging. And what better way to use that new role than by launching an offensive strike against FDA?
In the early days of discussion over a regulatory pathway for biosimilars, Abbott Laboratories Inc. wasn’t exactly considered a major player in the innovator biologics space.
When Congress first began to deliberate about “follow-on biologics” more than a decade ago, Abbott was a diversified company with...