Regs and costs will bring a decade of limited biosimilars development in the US

In March 2010, the Biosimilars Act was passed as part of the Affordable Care Act (ACA) and created an abbreviated regulatory pathway for the FDA to approve “biosimilars” – complex, large-molecule drugs made from living cells that are very similar, but not structurally identical, to established reference biological entities. Policymakers hope that biosimilars can fulfill a similar price competition role for biologics that generics have delivered for small molecule chemical entities. Generic products have yielded large drug cost savings and now account for over 80 percent of U.S. drug prescriptions.

Healthcare usage of biological drugs has been growing rapidly in recent years, now representing eight of the top 20 largest selling drugs in the United States. They have resulted in substantial health care benefits for patients and are targeted to many life-threatening and disabling diseases including cancer, rheumatoid arthritis, and MS. At the same time, these entities can cost tens of thousands of dollars or more per course of treatment.

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