FDA Aims to Bring More Biosimilars to Market

Recent analyses have found that the U.S. is lagging behind Europe in the use of cheaper generic versions of branded biologic drugs, or biosimilars, but the U.S. Food and Drug Administration (FDA) is now working on policies to increase use of biosimilars.

“There’s no silver bullet here in terms of trying to make this market really go gangbusters,” FDA Commissioner Scott Gottlieb, MD, said at CNBC’s Healthy Returns conference. “I think this is going to be a slow build.”

One specific action the agency is working on will make it more difficult for branded biologics to slightly modify products and then file for new patents – which extends the exclusivity of the reference product and prevents biosimilar manufacturers from developing their own generic version. Another policy will make it more difficult to vary the manufacturing of existing biologics; this makes it challenging for biosimilar manufacturers to create a copy because the biosimilar has to be studied against every variant of the reference product.

Dr. Gottlieb also expressed concern about whether the consolidation of pharmacy benefit mangers and pharmaceutical companies (Aetna-CVS and Cigna-Express Scripts) could block the entry of biosimilars to the market.

Sources: CNBC, March 28, 2018; Reuters, March 28, 2018.