July 25, 2005 -- The increasing prevalence of biologics raises the inevitable question: will generic versions replace these drugs once their patent protection expires? Erythropoietin, introduced in 1988, and a blockbuster drug, is nearing the end of its IP protection, so companies are gearing up to introduce generic versions. But biologics are several orders of magnitude more complex to manufacture than non-biologics. There are several key questions that must be answered about the approval process, each of which will have a large impact on how easy, or how costly, the approval process will be. We discuss the issues...
