FDA approves first biosimilar drug for US sales, Zarxio
07 Mar 2015
The Food and Drug Administration (FDA) this week approved the first biosimilar drug for use in the US, called Zarxio produced by Sandoz. The drug is designed to prevent infections in cancer patients who were taking chemotherapy.
The drug was a very close copy of an existing drug called Neupogen, produced by Amgen.
Zarxio had been approved for use in Europe since 2009, but it had not made its way into the US partly due the absence of a regulatory path to bring biosimilars - or approximate copies of drugs in a class called biologics - to patients.
An expert panel in January, made a unanimous recommendation that the FDA approve the drug.
The FDA approval of Zarxio marked a significant milestone for the US health care system according to Carol Lynch Global head of biopharmaceuticals and oncology injections for Sandoz.
According to The New York Times, the approval might pave the way for more affordable alternatives to a whole class of complex and expensive medications. The approval of the drug would help open the door to potentially cheaper lifesaving medication for millions.
Unlike most medications that are synthesized from chemicals, biologic drugs are made with living cells.
Biotech giant Amgen had for decades sold some of the top-selling drugs in the US and had, until now, little competition. However, that ended yesterday with the FDA's approval Zarxio.
The development is expected to usher in a new era of fierce competition - and lower prices - in the multibillion-dollar biologic drug market.
The FDA's decision, the first approval of a so-called biosimilar in the US, comes from a move set in motion in 2010 by Affordable Care Act provisions designed to cut the cost of biologics to patients.
Biologics had until now enjoyed US regulatory protection from copycats, or biosmilars, because biologics were not included in the 1984 law that cleared the way for low-cost generic pharmaceuticals.
The changes would open up the US market for these drugs, and though Amgen and other major biologic makers would lose from new competition, they offered huge new opportunities too.
The newly approved Zarxio, was only the first of many Amgen drugs being copied, but the company was also pursuing FDA approval of two more Amgen drugs: Neulasta, which like Neupogen boosted white blood cell counts, and Enbrel, which treated rheumatoid arthritis.
An application from Hospira Inc had also been received by the FDA for approval of a biosimilar version of Amgen's anemia drug Epogen.
