FDA panel backs lower-cost version of J&J's top-selling drug

AP News
Posted: Feb 09, 2016 5:07 PM

WASHINGTON (AP) — Federal health advisers have endorsed a lower-cost version of Johnson & Johnson's blockbuster drug Remicade, a pricey biotech medicine used to treat a number of inflammatory diseases.

The non-binding recommendation could clear the way for the cheaper medication from Celltrion, which would only be the second in a new class of quasi-generic biotech drugs to reach the U.S. market. These drugs, already available in Europe, have the potential to generate billions of dollars in savings for insurers, doctors and patients in coming years.

The FDA panel of outside experts agreed that Celltrion's version of the drug was highly similar to original Remicade, the standard set by the FDA for approval. But some of the experts said they would like to see more information on the drug's performance against certain diseases.