The first “biosimilar” drug has just been approved for use in the US by the Food and Drug Administration (FDA). With this, alternatives to a complete different class of complex but also less expensive drugs could be approved as well.
Sandoz, Inc. manufactures this new drug called Zarxio formulated to assist the body in the making of white blood cells used specifically for the treatment of cancer. This drug is also very similar to Neupogen, an existing medication.
Zarxio was first approved in 2009 in Europe but without proper regulations in place to bring biologic drugs to the market, it could not be used in the United States. However, a unanimous vote by an expert panel changed that in January, with the FDA just announcing the decision.
Biosimilar drugs will make it possible for additional therapies to be added as part of patient therapies, this according to Dr. Margaret A. Hamburg, FDA commissioner.
The approval of Zarxio is extremely significant since it opens the door to a new class of lifesaving drugs to become available for people in America, drugs that will ultimately be more affordable. Biosimilar drugs are part of the biologics class, which are drugs made from living cells. With this, patients will have other treatment options that do not include drugs synthesized from chemicals.
Other popular biologic type drugs currently available include Humira, Enbrel, and Remicade, although these focus on autoimmune diseases. Specific to cancer, biologic drugs available include Avastin, Rituxan, and Herceptin, which tend to be very expensive.
Many drugs with brand names were overtaken by most cost-efficient generic products. Until this latest development, biologic drugs had no real competition, meaning people were forced to pay high dollar for treatment. As explained by Ronny Gal, senior research analyst at Sanford C. Bernstein & Company, this is the first time low cost alternative biological drugs have been approved.
Researchers and medical professionals hope with the approval of Zarxio, older drugs used to treat cancer patients will become more affordable, which would pave the way for new breakthrough agents to be introduced.
When biologics were first developed in the 1980s, they were so specialized that it was virtually impossible for generic alternatives to be created. Fortunately, with the advances in science but sadly an increasing number of patients dying from cancer, pharmaceutical companies began working on the development of biosimilar drugs, which are very similar.
Compared to brand name logical drugs, biosimilar drugs will cost roughly 35% less. However, some experts believe that in some cases, discounts for Zarxio and other bio similar drugs could go as high as 90%.