efficacy profile is established via analytical and cellular data,
not through efficacy data ie, not through clinical trials. Having
said all this, the biotech industry may be erecting barriers to
slow biosimilars into the marketplace. The name brand companies
through name brand recognition may promote that with
30 years of experience their manufacturing processes are most
trustworthy even if they decide to produce biosimilars. If they
are truly comparable to the originator products, biosimilars offer
the possibility of decreasing cost and offering more patient
therapeutic benefits. The question to be answered is whether
the analytical techniques employed can elucidate a comparable
efficacy/safety profile to the originator.
In conclusion, many psoriasis sufferers do not have access to
effective therapies because of high cost. Reducing the cost of
biologics should increase patient access. As technology advances,
analytic techniques should help provide an effective
method to predict efficacy and safety of biosimilars prior to
human use. Should biosimilars show comparable analysis to
the originator insurance companies will likely enforce the use
of biosimilars prior to approval of proprietary biologics.
Acknowlegments
Elise Nelson LPN helped with the preparartion of this article.
Disclosure
The author has not declared any relevant conflicts.
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AUTHOR CORRESPONDENCE
Jerry Bagel MDdreamacres@aol.com