“The Food and Drug Administration announced on Wednesday that it would ease regulatory roadblocks for low-cost copycat versions of certain medicines.

Biosimilars, as the copycats are called, are seen as a crucial way to drive down drug prices. They are akin to generics of biologic drugs that are made through complex biological processes. Some well-known blockbuster drugs are now available as biosimilar competitors, including Herceptin, for breast cancer; Lantus, a widely used insulin; and Humira, for autoimmune conditions like arthritis.

The F.D.A. said it would advise drug developers that they generally no longer need to conduct expensive and time-consuming clinical trials aimed at showing that the copycat is just as effective as the original brand-name product. The agency also said it would push to make it easier for pharmacists to swap in biosimilars when dispensing a prescription, as is standard with generics…

The makers of biosimilars often spend several years and tens of millions of dollars conducting a clinical trial to show that its version is as effective as the original brand-name version. Under the F.D.A.’s proposed changes, developers would still have to show that their molecule and manufacturing process are similar.

Dr. Marty Makary, the F.D.A. commissioner, said at the news conference that the move would halve the current five- to eight-year timeline to win approval for a biosimilar. He said the changes would save biosimilar manufacturers tens of millions of dollars in development costs, saying that could be passed down in the form of lower costs for payers and patients.”

From New York Times.