The Food and Drug Administration (FDA) has given green signal to the first so-called ‘biosimilar’ drug for use in the US as the less expensive alternatives to a complete class of costly and complex medications.
Pharma company Sandoz was given a go ahead for the marketing of its drug Zarxio for preventing common infections in cancer patients under chemotherapy procedure.
Hailing the bright prospects of biosimilar medications in a statement, FDA commissioner Dr. Margaret A. Hamburg said, “Biosimilars will provide access to important therapies for patients who need them.”
Biosimilars, as the name suggests, are nearly the similar copies of drugs which are available in a class called biologics.
Medical analysts say the drug is very much similar to that of an existing medication called Neupogen, manufactured by Amgen.
Europe gave approval to Zarxio in 2009 to be marketed under the name ‘Zarzio’. However, it was not sold in the US market as no regulatory pathway prevailed in order to introduce biosimilars in the country. However, an expert panel unanimously recommended this drug in January this year to be approved by the FDA. Acting on the tip of the panel, the regulatory agency on Friday announced that it will look into the recommendations.
The approval by the FDA is crucial because it has opened the doors for a new class of potentially inexpensive drugs that can be life-saving for millions of Americans.
Biosimilar drugs involve biologic ones that are made up of living cells and purely not chemically synthesized as in the case of typical medications. Some of the popular biologic drugs include Herceptin and Avastin for cancer treatment, and Remicade and Enbrel for autoimmune diseases.