The United States Food and Drug Administration (FDA) has backed the approval of biosimilar drug from Novartis AG. The new drug, is a copy of Neupogen, created by Amgen.
Neupogen, an injectable biologic drug, is an anti-cancer drug taken by patients suffering from breast cancer and is usually prescribed to those undergoing chemotherapy to prevent infections. Biologics, unlike traditional medication, works on targeted parts of the immune system.
Biosimilars are a more affordable version of biologics. The latter is more expensive and complicated compared to chemical drugs, since they are made from living cells. Biologics have not had any competition before, and if approved, Novartis AG's biosimilar drug will be a first in the country.
The biosimilar, according to the FDA, "meets the requirement for a demonstration of 'no clinically meaningful differences' between the proposed product and the reference product in terms of safety, purity, and potency."
Chemotherapy lessens a patient's white blood cell (WBC) count, which may eventually lead to a "neutropenia."
Neutropenia is a condition where a person suffers from an abnormally low neutrophil count (a type of WBC). Neutrophils helps the body fight infections that are caused by fungi and bacteria.
"The lower your neutrophil count, the more vulnerable you are to infectious diseases. If you have severe neutropenia - fewer than about 500 cells per microliter of blood - bacteria normally present in your mouth and digestive tract can cause infections," The Mayo Clinic explained on their official website.
The biologic Neupogen from Amgen has sold $1.2 billion last year alone. If the FDA will give a nod to the panel who approved the biosimilar from Novartis AG, the U.S. government may save an estimated $44 billion in a span of ten years through the use of biosimilars.
FDA was only granted the authority to approve biosimilars nearly five years ago under the Obamacare Act. The process in approving these types of drugs are more complicated compared to chemical generic drugs due to the fact the living microorganisms cannot be exactly copied.
Europe has started approving and using biosimilars in 2006. The Neupogen biosimilar from Novartis is sold in the European market as "Zarzio."
