Is FDA Biosimilar Regulatory Process Defeating Purpose of BPCIA?

via Biosimilar Development
March 29, 2016
By Anna Rose Welch

According to Dr. Bert Liang, CEO of the biosimilar company Pfenex, the establishment of the Biologics Price Competition and Innovation Act (BPCIA), at least conceptually, has been more efficient than Hatch-Waxman. However, when it comes to developing the policies that will shape the biosimilar market and ultimately impact its success, Liang says that there is a lot of reinventing the wheel.

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