"Generic" Biologics? continued...
As part of the Healthcare Reform Act, Congress helped pave the way for cheaper versions of biologics, often referred to as "follow-on biologics." After a company has had 12 years of exclusivity on a biologic, other companies can produce similar versions of it, known as a "biosimilar." However, the process involved in producing a biosimilar is more complex than that involved in producing a traditional generic drug.
Unlike chemical-based drugs, biologics are made from living sources. It is more difficult to prove that a biosimilar is as safe and effective as the original biologic. The FDA offers guidance as to the specification that these drugs must meet in order to be called "biosimilar."
Because companies will likely have to invest in expensive clinical studies to prove their new products are biosimilar to the original, and due to the high costs of manufacturing biologics in general, patients may not save much with these types of drugs.
In Europe, where biosimilar products are already on the market, these therapies save people only about 25%-30%. It may be a few years before more is known about the process involved in releasing biosimilars and how much money patients might actually save.