Biologics Price Competition and Innovation Act (BPCIA)

Key facts

Enacted

March 23, 2010, as part of the Affordable Care Act

Codified in

Sections 351(k) and 351(l) of the Public Health Service Act

Reference product exclusivity

12 years from first licensure

Filing bar

No biosimilar application until 4 years after reference licensure

First U.S. biosimilar

Zarxio (filgrastim-sndz), approved March 2015

What is the BPCIA?

Before 2010, biologics licensed under the Public Health Service Act had no abbreviated approval route comparable to the generic drug pathway created by the Hatch-Waxman Act. The BPCIA, enacted within the Patient Protection and Affordable Care Act, filled that gap by adding Section 351(k) for biosimilar and interchangeable products.

A biosimilar must be highly similar to its reference product, with no clinically meaningful differences in safety, purity and potency, but it does not have to be identical. An interchangeable product meets additional standards so that, where state law allows, a pharmacist can substitute it without asking the prescriber.

How the BPCIA framework works

The law has several moving parts:

• Section 351(k) application: an abbreviated Biologics License Application (BLA) built on analytical, animal and clinical data comparing the product with its reference product.
• Reference product exclusivity: the FDA cannot approve a biosimilar until 12 years after the reference product was first licensed, or accept an application until 4 years after.
• First interchangeable exclusivity: a period during which a later product cannot be deemed interchangeable with the same reference product.
• Patent dance: a staged exchange of patent lists and contentions under Section 351(l), which the Supreme Court held in Sandoz v. Amgen (2017) cannot be enforced by federal injunction.
• Notice of commercial marketing: the biosimilar applicant must give 180 days of notice before first commercial marketing.
• Transition provision: on March 23, 2020, certain biological products approved under New Drug Applications, such as insulins, were deemed BLAs.

Why the BPCIA matters

The BPCIA sets the earliest date biosimilar competition can arrive for some of the highest-spend drugs. Analysts combine licensure dates from the Purple Book with the 12-year exclusivity rule and patent litigation to model when biosimilars can launch against a reference product.

Approval and launch often diverge. Patent settlements have kept approved biosimilars off the market for years, and uptake after launch depends on payer formularies, rebates and interchangeability rules that are still evolving, including 2024 FDA draft guidance proposing that switching studies are generally not needed to show interchangeability.