Rapid Rise in IND’s for Biosimilars

By Bob Bohrer
[Cross-posted on Pharmaceutical Policy.]

According to a story by Bronwyn Mixter in Bloomberg’s BNA BIOTECH WATCH, the FDA has received at least twenty-five IND’s for biosimilar development programs. Some quick perspective on that is appropriate. Twenty-five initial IND’s for the development of new small molecule drugs for cancer or autoimmune disease would face many years of clinical trials and long odds against approval (DiMasi et al estimated the approval rate at sixteen percent to nineteen percent). However in this “a little brave” and “a little new” world of biosimilar development, clinical development programs are likely to be much shorter in duration than development programs for new drugs or innovator biologics, and the success rates are likely to be very high, as I indicated in a pharmaceuticalpolicy.blogspot.com post of May 19th, 2014. The DiMasi study referenced above estimated the large molecule success rate at thirty-two percent; and, biosimilars are not only within that large molecule category, they are copies of drugs that have already been shown to be reasonably safe and effective. So it is very likely that we will see filings for the approval of more than twenty biosimilars in the next three years.

It will be very interesting to watch the rapidly developing biosimilar marketplace.