By Michael Cottler, Joshua Whitehill, Alison
Siedor
The 2010 Biologics Price Competition and
Innovation Act (BPCIA), enacted as part of the Affordable Care Act, set up an
abbreviated biosimilar regulatory pathway and a unique litigation framework for
resolving related patent disputes. While regulatory and litigation activity for
biosimilars began as a trickle — with the first patent case filed in 2014 and
first Food and Drug Administration approval in 2015 — it has steadily increased
each year. Today there are nine FDA-approved
biosimilars, including three on the market, and more active BPCIA
litigations. This year saw numerous new
complaints about the law, five new FDA approvals, another biosimilar launch,
the first U.S. Supreme Court decision concerning on the topic, the first jury
trial and damages award in a biosimilar case, and other significant
activity.
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