US Regulatory Agency Approves First Generic Biotech Drug

The US Food and Drug Administration approved Zarxio. It is the first biosimilar product approved in the United States.

 

WASHINGTON (Sputnik) — The United States approved the first biotech drug, the US Food and Drug Administration (FDA) announced in a statement on Monday.

“The US Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States,” the FDA statement read.

FDA approves first biosimilar product in the United States. http://t.co/3qrCPo7ijZ

— U.S. FDA (@US_FDA) March 6, 2015

Zarxio will be used to treat individuals that have cancer, leukemia, severe chronic neutropenia and those who are undergoing different forms of chemotherapy and treatment.

“Biosimilars will provide access to important therapies for patients who need them,” FDA Commissioner Margaret Hamburg said in the FDA statement.

“Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards,” Hamburg added.

The FDA approval of Zarxio came after an extensive review of the drug under US President Barack Obama’s Biologics Price Competition and Innovation Act (BPCI) of 2009, which took effect under Obama’s Affordable Care Act signed into law in March, 2010, according to the FDA statement.

The FDA is a US public health federal agency that regulates food, pharmaceutical drugs and tobacco products.