By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq.
The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of the Affordable Care Act.
Biosimilars are highly similar, but not identical, copies of FDA-approved biologics, known as “reference” products. Biologics are used to treat a variety of diseases and medical conditions, including cancer. For many years, biosimilar development was thought to be too complex and too costly to advance, and exclusivity patents for reference biologics prohibited developers from marketing competing biosimilars. Now that those patents have started to expire, biosimilar development can finally begin, at a potentially huge benefit to patients.
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.