Following the release of the FDA’s purple book, the World Biosimilar Congress (WBC) USA launched in 2015 to bring focus to the important and distinct issues facing the biopharmaceutical industry. When it comes to developing and commercializing biosimilars in the United States from the payer or biosimilar manufacturing perspective, WBC is the largest event in North America.
Since last year’s event, the industry has matured, and now the industry waits for the floodgates to open while trying to predict hurdles and challenges that will be faced in an environment with limited regulatory guidance.
That is why for 2016, we are growing the WBC-USA even further. We will be bringing in:
- More US-based case studies on launches and lawsuits
- More patients and physicians to understand the hindrances to uptake including models in countries where it has happened
- New discussions on properly utilizing a sales team in the biosimilar industry
- More talks on clinical trial design to achieve correct status through a PBM.
Who is going to be there?
- Patrick Lucy, Chief Business Officer, Pfenex
- Jeff Myers, CEO, Medicaid Health Plans of America
- Steve Miller, Chief Medical Officer, Express Scripts
- Steinar Madsen, Medical Director, Norwegian Medicines Agency
- Jay Kothari, VP, Strategic Initiatives, Zydus Cadila
- Doug Monroe, Project Manager, Biotechnology, Emerging Technology, and Specialty Pharmacy, Kaiser Permanente
- Niraj Chhaya, Lead Risk Management, Global Pharmacovigilance, Boehringer Ingelheim
Topics to be covered include:
- Leveraging emerging markets for a successful global biosimilars development portfolio: A perspective from a leading emerging market company
- Designing clinical trials to achieve not just right regulatory data but also the correct status through a pharmaceutical benefits manager
- The data gap: generating more data on biosimilar efficiency to increase their uptake by caregivers
- Ensuring patient compliance and satisfaction in the rapidly changing biosimilar landscape
- Using data and clinical models to show biosimilarity in coping with unclear guidelines: global vs US approaches
- How the varying degrees of uptake in Scandinavian countries can serve as a model for ways companies can interact with industry stakeholders to improve biosimilar adoption in the U.S.