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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