Biotechnology and pharmaceutical companies are awaiting the FDA’s new regulations for implementing the 2010 Biologics Price Competition and Innovation Act (BPCIA), which will aim to provide an expedited approval framework for follow-on biologics. While industry leaders can only speculate on the content of those regulations, Finnegan partner Bill Lewris compares the key differences between the BPCIA and Hatch-Waxman Act, including what type of follow-on biologics the BPCIA contemplates, exclusivity periods, and the patent litigation process.

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