Originally published in Pharma’s Almanac

The biosimilars market in the United States continues to lag behind the rest of the world. However, there are promising signs that the market is poised to gain momentum.

Expanding Biosimilars Market

Given biologics’ complexity, the global scientific community has rightfully questioned its collective understanding of these therapeutics. Could the industry really develop and manufacture therapeutics that would behave similarly and have the same — or at least similar — clinical outcomes as an innovator biologic? Were biosimilars interchangeable with innovator drugs? These questions were warranted, and the world pushed forward to address them. Most global markets achieved confidence in their biosimilars review and approval processes. Additionally, most nations concluded that their people were better served by having access to lifesaving medications rather than waiting until every question was answered fully.

The United States trailed the EU and other nations in implementing legislative and regulatory constructs to support its biosimilars market. The EU was the first to release biosimilar guidelines, in 2005. The biosimilars market was legislatively created in the United States by the signing of the Biologics Price Competition and Innovation Act (BPCIA), part of the Affordable Care Act, in March 2010. However, the U.S. Food and Drug Administration (FDA) did not release its first biosimilars draft guidance until 2012.

The commercial U.S. biosimilars drug market was effectively established in 2015 with the approval of Sandoz’s Zarxio®, which quickly established itself by…. continue reading article