On March 6, 2015 the Food and Drug Administration (FDA) approved the first biosimilar drug for use by patients in the United States (see FDA press release). The drug called Zarxio (filgrastim-sndz) is produced by Sandoz and is similar to Amgen’s Neupogen (filgrastim). Both are approved to treat certain kinds of cancers and bone marrow transplants.
Biologic medicines come from living organisms. They are different from chemical medicines in that they contain large and delicate biological molecules such as proteins, must be injected or infused since stomach acids would damage the molecules, and are usually much more expensive than chemical medicines due to development and complicated production costs. Given the high development costs associated with biologics, they are given an extended patent length of 12 years in the United States. When a chemical drug looses its patent protection, companies produce generics that are exact chemical matches. Generics are widely used and are much cheaper than the original drug. Given the complexity of biologics, exact chemical matches are replaced with scientific equivalency meaning that the biologic is similar in action but not exactly the same – thus the name “biosimilar” being used for these drugs (Entine, 2012).1
Some of the most popular RA biologic medicines stand to loose patent protection in the United States in next few years.
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