FDA Panel Recommendation On Arthritis Drug Knockoff Could Clear Way For More Biosimilars
The non-binding approval of the lower-cost version of Johnson & Johnson's drug Remicade could signal the Food and Drug Administration will use looser criteria for marketing approval than some people expected, analysts say. In other FDA news, the agency cracks down on a Florida stem cell clinic.
The Wall Street Journal:
Panel Recommends FDA Approval Of Remicade Knockoff
A U.S. regulatory panel vote on Tuesday is a win for companies developing lower-cost copies of pricey biotechnology drugs, but it could be a while before patients see them. An advisory panel to the Food and Drug Administration voted to recommend the agency approve the sale of a knockoff version of Johnson & Johnson’s arthritis drug Remicade, which had U.S. sales of $4.45 billion last year. The copy was developed by Celltrion Inc. and licensed to Pfizer Inc. (Loftus, 2/9)
The Associated Press:
FDA Panel Backs Lower-Cost Version Of J&J's Top-Selling Drug
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. 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. (Perrone, 2/9)
Health News Florida:
FDA: Florida Stem Cell Clinic Violates Law
A South Florida clinic that promotes controversial stem-cell treatments for a wide range of ailments is among the centers receiving a written warning that it is violating federal public health laws. The U.S Food and Drug Administration’s letter was addressed to Dr. Thomas A. Gionis, owner and chief surgeon of the Miami Stem Cell Treatment Center located in Boca Raton. Gionis also owns a stem cell treatment center in Irvine, Calif. (Gentry, 2/9)
