BPCIA
The 2010 US law that created the regulatory + patent pathway for biosimilars.
Definition
The Biologics Price Competition and Innovation Act (BPCIA) of 2010 created the 351(k) abbreviated pathway for biosimilar approvals, gave reference biologics 12 years of regulatory exclusivity, and established the "patent dance" — a structured pre-litigation exchange of patent lists between the biosimilar applicant and the reference sponsor.
See also
- Biosimilar — A biologic product highly similar to an already-approved reference biologic.
- Patent cliff — The steep drop in revenue when a drug's patents expire and generic competition launches.