With patents for dozens of biologic drugs expected to expire within the next five years, the value of bringing biosimilar alternatives to the market has never been clearer for drug manufacturers. In the United States, the FDA has created an abbreviated licensure pathway for biosimilars, but many pharmaceutical companies and biotech firms struggle in understanding how-to:

• Provide the pre-clinical and clinical data needed to demonstrate similarity
• The speed and complexity of advancing a biosimilar drug development project
• Design comprehensive clinical trials needed to prove safety and efficacy in humans

It’s because of this that we’re bringing you the Biosimilars Clinical Studies & Analytical Similarity Summit. This November, we’ll be providing key insights from thought leaders into the biggest challenges in the analytical and clinical phases of biosimilar drug development, from responding to additional regulatory challenges, demonstrating thequality attributes needed to prove interchangeability, and successfully moving through the third phase of clinical trials.