Playing to a mixed audience of boos and cheers, the Trans-Pacific Partnership (TPP) was finalized Monday with the U.S. agreeing to biologic exclusivity of five to eight years.
The provision aligns with the exclusivity offered by some of the countries that are party to the agreement Australia and Mexico both offer five years of exclusivity, while Canada and Japan provide eight years. But it falls well short of the 12 years mandated in the U.S. under the 2010 Biologic Price Competition and Innovation Act, which authorized the FDA's biosimilar pathway.
Regardless of the TPP, 12 years is still the law of the land in the U.S., Kirsten Axelsen, vice president of worldwide policy at Pfizer Inc., said at a Pew Charitable Trusts forum on paying for drug value. The treaty doesn't change that.
But given a growing convergence of escalating drug prices for both small molecules and biologics, recent incidents of price gouging, a shift in