Major drug makers have a decision to make regarding entrance to the US biosimilars market. Companies must choose how to develop the drugs. They can develop them as new products, which would involve extensive and expensive clinical trials, or opt for a quicker route, similar to that used by generic drugs. Companies hope to begin development right away, since biosimilars take longer to develop than chemical-based generics; it can take years to introduce a biosimilar product. It is also assumed the drugs will be sold under a specific brand name, which means companies will want to establish an early foothold in the market. The FDA has created a group to set up policies and procedures, which are expected, in the vein of generic drugs, to allow the biosimilar application to refer to clinical trial results of the original, bypassing the expense of new trials. However, companies will likely be required to provide clinical data to indicate that their products have no major differences from the branded version regarding safety, purity and potency—which could add even more time onto the process.

Source: Wall Street Journal