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

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

After nine hours of discussion the FDA panel of outside experts voted 21-3 in favor of approval for all the diseases currently indicated on Remicade's label.

FDA scientists attempted to assure the panel that Celltrion's data virtually assured the drug would work as well as Remicade across multiple diseases, even without formal studies showing those results.

"The clinical data would only provide assurance for what we already know to be true, that the drug works," said Dr. Badrul Chowdhury, a director in the FDA's office of drug evaluation.