FDA has been busy preparing for the day when the first biosimilar application is filed. In February, FDA published three draft guidance documents on biosimilars. In May, FDA held a public hearing on the guidance. And earlier this week, FDA announced biosimilar user fee rates for fiscal year 2013.
Patent lawyers have been busy preparing too. On September 11th, I will be speaking on "Best Practices in Portfolio Management During the Patent Exchange Process" at IIR USA's 13th Annual Business of Biosimilars & Generic Drugs conference, to be held in Boston from September 10-12. According to the conference producer:
Initially established in 1999 as "The Generic Drugs Summit," this event from the outset helped shape best practice and performance standards in the generics industry. In early years, a major topic of discussion was the potential for "biogenerics," with the biotech industry hoping that these molecules could be created and approved through long-tested and familiar methods. When it became clear that a radically different pathway would be required, we became the first commercial event to address the regulatory and commercialization concerns relevant to follow-on biologics, under our new banner, "The Business of Biosimilars and Biobetters." Now building off the accumulated expertise of our long history, we are proud to offer "The Business of Biosimilars and Generic Drugs" in order to illuminate the most urgent and timely topics relevant to follow-on biopharmaceuticals. This year's program features crossover topics of interest to both groups, as well as breakout sessions to give equal time when their needs diverge.
Here is the complete agenda:
- Morning Summit: Biosimilar R&D Scenario Planning Session
- Afternoon Summit: choose from "Map the Strengths, Weaknesses, and Defenses of your IP Assets to Prepare for the Challenges of the Follow-On Process" or "Assessing the Immunogenicity Potential for Biosimilars"
- Think Different--Navigating the Brave New Globalized Life Science Industry
- The World is Flat--Make Sure Your Sales Are Not--Commercializing Generics in Global and Emerging Markets
- The New Paradigm in Strategic Partnerships for Follow-On Biopharmaceutical Development
- Reimbursement Strategies for Generics and Biosimilars Around the World
Track 1: Market Access for Biosimilars
- The Strategy and Case Study of Global Biosimilar Development
- Overview of Biosimilar Trends in BRIC Countries
- The Future of Biosimilars in Specific Emerging Markets
- Combat Misinformation About Biosimilars
Track 2: Market Access for Generics
- Preparing Global Manufacturing Processes for Product Rollouts
- Direct-to-Pharmacy and Direct-to-Consumer Rebate Strategies: What's Coming Next?
- Analyzing the Regulatory Criteria That Your Generic Drug Candidate Must Meet
- Establishing R&D Methods and Timetables That Will Streamline Your Expansion to New Markets
Track 3: Legal/IP for Biosimlars
- Turn Antitrust Laws to Your Advantage in the Generics and Biosimilars Marketplace
- Best Practices in Portfolio Management During the Patent Exchange Process
- Experiences from Developing Biosimilars for EMA: Unique Perspectives from Growth Hormones to Monoclonal Antibodies
- Adapt to New Regulatory Requirements for Biosimilar Approval and Success
- Outlook and Strategic Impact of the U.S. Biosimilar Approval Pathway
- Regulatory Extrapolation of Therapeutic Indications for Complex Biosimilars: Clinical and Regulatory Updates, and Ways to Proceed
- Improve and Approve: Boost the Safety and Convenience of Biobetters, and Navigate the New Regulatory Environment
- Building Product Awareness and Acceptance: What Can Biosimilars and Generics Learn from One Another?
- When Being the Same is Good Enough: Building Public Confidence and Interest in Biosimilars
- Preparing for IP Challenges: What Originators and Follow-On Companies Need to Know
For more information or to register, please visit the conference website. To save 25%, register using promotion code XP1786OBB.