Friday, September 12, 2014

Biosimilars And Gene Patents In This Week's News

According to a story by Bronwyn Mixter in this week’s 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 my 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 development of the biosimilar marketplace.

In a second news item of note, the Australian Federal Court upheld the patentability of gene sequences, a decision that is in direct conflict with the patentability of naturally occurring gene sequences here in the U.S.  While Nature decried the Australian decision in a brief editorial opinion, the rapid development of whole genome sequencing is, as I have previously opined, likely to make this particular controversy much ado about nothing.  Of far more concern than the relatively narrow issue of patents on gene sequences is the huge uncertainty over the scope of patentability created by the U.S. Supreme Court’s decisions in both the Myriad case and the prior decision of Mayo v. Prometheus.  I would hope that the uncertainty these decisions create is resolved in the near future in ways that promote further innovation in the pharmaceutical treatment of serious diseases.

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