It may soon be easier to get approval for new biotech-based medicines or biologics that are similar to ones currently on the market. On February 9, the FDA published draft guidelines providing a fast track to get FDA approval of biosimilars—new biologically-produced drugs that are similar to ones already in use.
Although some biotech-based medicines have been used since the 1980's, there are no generic forms of these type of drugs. The reason is that, although chemists can easily reproduce formulations of the active chemical in traditional drugs, biologics cannot be synthesized by mixing exact amounts of chemicals. Biologics are made in living growing organisms, such as cultured cells, using genetic engineering. The manufacturing process for biotech drugs is completely different and, as a result, the FDA guidelines for fast track approval of standard generic drugs do not apply to biologics. Any new biologic, even if it is almost the same as one already being sold, has to go through the entire FDA screening process—including clinical trials. This process is very time consuming and costly. However, the draft guidelines published today will change. When adopted, they will provide a fast track approval process for biosimilars.
The introduction of these new guidelines is a result of the Affordable Care Act, signed into law last year. For more details, read the FDA press release and Associated Press coverage.
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