Pleased to be chairing the Biosimilars World Congress (23-24 May in San Diego, CA) panel discussion of the most important topic, “how to expedite approval of biosimilars.” I am delighted that the FDA has joined us, as well as several key stakeholders; sharing my years of developing biosimilars, this is going to be the most useful discussion for the developers, prescribers, payers and the regulatory agencies. Don’t miss this out.
I will be presenting the following topics:
Why is the bridging study needed in clinical trials when using multiple reference products?
If there no clinical meaningful difference, then why aren't biosimilars substituted?
Why is the industry so keen on conducting trials in patients, when the FDA is not?
How can the FDA and developers join hands to expedite approval of biosimilars?
What can the payers do to force entry of biosimilars to the US markets at reduced price?
I am sharing my first-hand experience in dealing with each of these topics, having taken several product through FDA and I believe that a sea of change is coming that will allow the BPCIA to provide the benefits anticipated for so long.