Brand-new FDA guidelines have created a long-awaited shortcut
for bringing biosimilars—cheaper versions of biologically
derived pharmaceuticals—to the U.S. market. But the
pathway won't be nearly as straightforward as the one for
generic versions of less complex, chemically based drugs that was
created under the Hatch-Waxman Act in 1984.
Unlike the Hatch-Waxman route, the biosimilar guidelines issued
in February call for drug makers to be in regular contact with the
FDA during virtually every step of the development process,
explains Morrison & Foerster attorney Cary Miller. Many
decisions will be made on a case-by-case basis. "I think the
approval process will evolve as companies develop their
products," she says.
"The uncertainties associated with the new process could
spur companies to forgo it in favor of the traditional licensing
process," adds Stephanie Hsieh, former Of Counsel at Morrison
& Foerster. Some have also raised concerns about the amount of
confidential information an applicant might have to disclose
through the new process.
Despite the difficulties, it appears that many companies will
press on with biosimilars efforts. One research firm has estimated
that U.S. sales of biosimilars could reach $8 billion by 2020.
Because of the generality of this update, the information
provided herein may not be applicable in all situations and should
not be acted upon without specific legal advice based on particular
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