2015: year of the biosimilar


2015: year of the biosimilar


The FDA could approve the US’s first biosimilar product any day now. But is the country ready for the wave of biosimilar applications that will surely follow, and how quickly can these cut-price drugs come to market? LSIPR reports.

In March 2010, US President Barack Obama signed the Patient Protection and Affordable Care Act, also known as Obamacare, into law. It was preceded in 2009 by the Biologics Price Competition and Innovation Act (BPCIA), which introduced a shortened pathway for approving biosimilars, medicines that have been developed to be close to existing biologic drugs.

Last July, the US Food and Drug Administration (FDA) approved for review the US’s first biosimilar application—Sandoz’s Zarzio.

Zarzio is a follow-on version of Amgen’s drug Neupogen (filgrastim), which stimulates the growth of white blood cells in the body, and is used to treat patients who have low levels of white blood cells because of cancer, or have recently undergone a bone marrow transplant.

Biosimilar, Zarzio, BPCIA, FDA, Sandoz, patent, Myriad