Robinson Bradshaw

Topic: follow-on biologics

2011 Personal Genomics Preview: It’s Déjà Vu…

Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked: 1. Will the $1,000 genome live up to the hype? 2. Will personal genomics stay DTC? 3. How will the ongoing gene patent debate affect the progress of personalized medicine? 4. […]

GLR Update: The Fate of Follow-On Biologics Remains Uncertain

When the GLR looked last month at the ongoing debate over follow-on biologics, we noted that one of the most contentious issues in creating a regulatory approval pathway for these generic biological drugs centered on the appropriate length of the market exclusivity to be provided to developers of original biologics. Even as we asked the […]

Follow-on Biologics: How Much Incentive Do We Need?

After almost a full year of debate, a pathway for approving “follow-on biologics” or “biosimilars” continues to be a hot topic in Congress. We are all familiar with generic versions of brand-name drugs, and the federal regulatory scheme sets out well-defined shortcut procedures for approval of generics. Congress is now grappling with designing procedures for […]