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 2nd Annual Biosimilars Summit. This upcoming February, we’ll be discussing some key insights from thought leaders into the biggest challenges in the analytical and clinical phases of biosimilar drug development, from addressing current regulatory struggles, demonstrating the quality attributes needed to prove interchangeability, and successfully entering the market.