Biosimilar Action Plan (BAP)

On July 18, 2018, in Documents, Industry News, by AQ-IQ LLC

Read the FDA’s Action Plan here

Excerpts from the plan: 

Generic drugs, for instance, represent 90 percent of all prescriptions in the U.S.1 Generic competition facilitated by the 1984 Hatch Waxman Act provided savings of more than $1 trillion to the U.S. health care system over a decade and generated $265 billion in savings in 2017 alone.2 However, until relatively recently, the FDA lacked a statutory pathway to approve follow-on versions of biological products.

Against the backdrop of these high costs to our nation’s health care system and the need to enhance access to these important products for patients, Congress passed the Biologics Price Competition and Innovation Act (BPCI Act), which established an abbreviated pathway for biologics, called biosimilars, in 2010. The BPCI Act was intended to strike a balance between access and innovation, providing a period of exclusivity for originator biologics and enabling a pathway for competitive biosimilars once exclusivity periods have lapsed. This is similar to the way the Hatch-Waxman amendments sought to establish balance between innovation for brand products and availability of generic competition.

The FDA will continue to play a critical role in facilitating increased access to biosimilars. The agency is taking steps to more efficiently manage our review and licensure pathways to facilitate biosimilar competition.

Visit FDA.gov for more information

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