Developments in biologics are of ever-increasing focus in drug development. Unlike more traditional pharmaceuticals in which innovator pharmaceutical and generic pharmaceutical companies remain separate, biologic developers often keep new reference molecules and biologics under the same roof. This panel session will highlight:
1. What are the alternating strategies for creating an innovator-side patent thicket, and finding holes in the patent thicket? Are later-filed patents more vulnerable? How and when are IPRs the best strategy?
2. What are the strategies for pursuing both sides of biosimilar development – on one side innovation, and on the other biosimilar product development? What about policy positions?
3. What are R&D strategies for pursuing both innovative drugs and biosimilars?
4. Are there any international implications to pursuing a two-phase strategy?
Ability Level: All
Session ID: 505692