Estimates for biosimilar approval in the United States range
anywhere from two to five years, but that may only be the start of some
considerable challenges for US drug makers.
The global market for oncology biosimilars is expected to
boom over the next few years and predictions have that market alone generating
between $6 and $12 billion by 2020. A
recent IMS report predicts the US will
have a direct impact on the global reach of these products and this potentially
lucrative business. Explains the author
of the report, “The US is the largest biologic market by size, and is pivotal
to the success of the overall biosimilar market.”
But if the U.S. is to become the factor everyone expects, it
will not be without overcoming their share of obstacles. The report found the US to be trailing the
rest of the world in biosimilar development primarily due to a complex regulatory
process.
Said Javier Coindreau, MD, vice president of global medical
affairs for Pfizer Biosimilars Business Unit, in a recent interview with Specialty Pharma
Times:
“One of the most important roadblocks is clarity in the
regulatory pathways. The pathways are evolving all the time, and this is
especially true in the biosimilar world. The current regulation doesn’t provide
the needed clarity for specific molecules. One of the most challenging parts is
when we submit drug submission packages with the best analysis finding the best
chance for being approved, sometimes we struggle in identifying what exactly
are going to be the demands of the regulatory agencies because the current
regulations have many grey areas that need to be clarified case by case.”
Among other obstacles are the struggle in proving a
biosimilar is the same product as the name brand. Not only is it difficult to prove that a
biosimilar is the same product as a name brand, but the process of proving that
similarity is not well defined.
Coindreau cited another reason that’s overlooked by
many. Difficulty in recruiting patients
for clinical trials is an obstacle not just for US drug makers, but for global
companies as well. He discussed the idea
that patients would be more apt to enter a trial for a new treatment as opposed
to one that is supposedly the same. “They
think if I’m going to enter a trial, I’m going to do it for a new molecule not
something that’s the same as the previous one,” he said.
Whether the approval for biosimilars in the US is two years
from now or five years, there’ll be a host of challenges for drug
companies. We’ll have more on those challenges
at the Business
of Biosimilars conference. Join
us October 20-22 in Boston, MA. Download
the agenda here to see what’s on tap.
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