US considers shortening marketing exclusivity to push forward USMCA

The Trump administration is considering shortening the period that big pharma companies’ biologic drugs are protected by marketing exclusivity from biosimilar competition.

The news comes as part of the administration’s efforts to secure Democratic support for the US-Mexico-Canada trade agreement,  The Wall Street Journal (WSJ) reported yesterday, December 2.

In the US, under the Biologics Price Competition and Innovation Act (BPCIA), the Food and Drug Administration grants biologics a 12-year exclusivity period during which biosimilars cannot be sold.

Citing people familiar with the matter, it said the Democratic Party had urged the administration to reduce the time that leading biologic drugs can exercise monopoly, by allowing biosimilars to come to market sooner.

Democrats want the current 12-year time period reduced, or at least new language put into the BPCIA to allow for a reduction.

According to the WSJ, this time period could drop from 12 years to ten, as the Trump administration is eager to move forward with the trade agreement.

The trade agreement was signed by all three participating countries on October 1, 2018, but US Congress is yet to ratify it. So far, only Mexico has ratified the agreement.

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