Biosimilars: Beyond the New Pathway for Approval

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Monday, February 11th, 2:00pm - 2:55pm

With patent expirations looming, pharma and large and small biotechs have been scrambling for “the next big thing.” The Affordable Care Act established an approval pathway for biosimilars and the FDA is working on additional guidance. What clinical and regulatory issues do companies need to address when it comes to developing a biosimilar? What will reimbursement look like and what can we learn from the European model? How will the FDA view interchangeability and how exactly will clinicians utilize these products in their practices? Key stakeholders will convene to discuss the challenges and market opportunities these products present and will peer into the biosimilars pipeline.

 

Panelists coming shortly