The U.S. Food and Drug Administration (FDA) has approved the first biosimilar drug called Zarxio, which can make way for more affordable drugs. Zarxio prevents any infections in cancer patients who are undergoing chemotherapy.
A biosimilar drug is considered a copy of an original drug and is made from living cells. Biosimilar drugs are effective as synthetic drugs, but they are relatively cheaper than original drugs.
On Friday, March 6, Sandoz, the generic pharmaceuticals division of Novartis, announced that the FDA has approved a drug called Zarxio for use in the U.S. Zarxio is considered a close copy of Neupogen, an existing drug that has been created by Amgen.
Even though Zarxio is the first biosimilar drug to be approved in the U.S., it has been in use as Zarzio in Europe since 2009.
Sandoz revealed that with Zarxio's approval, the company has achieved a big milestone not just for itself but for the entire healthcare system in the U.S.
"As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the U.S. biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the U.S.," said Carol Lynch, global head of Biopharmaceuticals & Oncology Injectables at Sandoz.
The FDA also announced that biosimilar drugs are as safe and as efficient as synthetic drugs.
"Biosimilars will provide access to important therapies for patients who need them," said Margaret A. Hamburg, Commissioner of FDA. "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."
A dose of Neupogen costs about $350, and Zarxio is expected to cost at least 15 to 20 percent lower. However, Sandoz has not revealed the exact price of Zarxio. Medical experts suggest that biosimilar drugs may also be available at a 90 percent discounted rate in comparison to the synthetic drugs.
The introduction of biosimilar drugs may lead to saving millions of dollars each year for patients and insurers, experts predict.
Market observers believe that Zarxio may help the U.S. healthcare system save about $5.7 billion in the next 10 years. There are about 11 more biosimilar drugs under development. If all of them are approved by the FDA and made commercially available, they could result in savings of about $250 billion.
Many pharmaceutical companies are already in talks with the FDA over 50 biosimilar drugs for 15 existing synthetic drugs. Market experts suggest that biosimilar drugs will make their way to about 70 percent of all prescriptions in the coming years.
Novartis sells biosimilar drug versions of Neupogen in more than 40 countries. The company announced that the biosimilar cancer drug accounted for $1.2 billion in sales across the world in 2014.
Photo: ZEISS Microscopy | Flickr
