10:54 AM

Opening the Biosimilar Bottleneck: Mounting FDA approvals, reduced costs may revive stunted U.S. market

Healio Rheumatology discusses the bottleneck in the number of biosimilars that have made it to the U.S. market, according to experts including HSS rheumatologist, David R. Fernandez, MD, Phd.

While the FDA approved 26 biosimilar therapies, many of them with indications for rheumatologic and inflammatory diseases, only two are currently available in the U.S. “There are definitely many factors. A major one is litigation by reference drug makers attempting to limit access of biosimilars to the market, in many cases having to do with patent enforcement. Many of these cases have been settled, with the outcome of delayed entry —meaning, the biosimilar drug will come to market years in the future, rather than immediately after it is approved by the FDA,” explained Dr. Fernandez.

Dr. Fernandez discussed additional factors delaying market entry, including costs and physician prescribing behaviors. “Many physicians are conservative in adoption of new therapies, particularly when switching well-controlled patients to a new agent. To overcome that, an effort must be made to familiarize oneself with new agents, to gain confidence and to use them more. At the moment, there are some theoretical concerns about interchangeability between the biosimilar and bio-reference agent, though there have been some reassuring studies on that point,” said Dr. Fernandez.

Read the full article at Healio.com/rheumatology.