The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc., called Remsima. The FDA usually, but not always, follows the advice of its advisory panels.
The independent panel determined that clinical trials of Remsima showed no clinically significant differences with Remicade in treatment of rheumatoid arthritis and ankylosing spondylitis.
Moreover, the panel agreed Remsima is likely as safe and effective for other conditions Remicade treats, including psoriasis and inflammatory bowel conditions, such as Crohn’s disease and ulcerative colitis, even though Remsima was not tested against those conditions.
Before the vote, Jay Siegel, J&J’s chief biotechnology officer, urged the panel to await results of an ongoing Celltrion study comparing Remsima and Remicade against inflammatory bowel disease before assuming that the medicines are similar in those conditions.
“Only direct clinical comparisons of (Remsima) and Remicade in active inflammatory bowel disease can provide the requisite assurance,” he said.
But the FDA has previously determined it may be appropriate to license biosimilars for additional conditions for which a branded product is approved, even if the biosimilar has not been tested for them.
Dr. Steven Solga, head of gastroenterology at St. Luke’s University Hospital in Bethlehem, Pennsylvania, told the panel it makes no sense to require biosimilars to be tested for every condition because such trials would be too small to deliver reliable results.
Some analysts expect Remsima to be introduced in the U.S. by 2018 and wrest sales from Remicade as well as from AbbVie’s Humira (adalimumab) and Amgen’s Enbrel (etanercept) , which also block the inflammation-causing protein tumor necrosis factor.
Celltrion and Pfizer have not disclosed what they might charge for Remsima, but a substantial discount from Remicade is expected.
Shares of J&J, AbbVie and Amgen fell sharply on Friday after FDA scientists issued a briefing paper backing Remsima. Shares of the drugmakers were little changed after-hours on Tuesday.
Remsima would become the second approved biosimilar in the United States, following Novartis AG’s September introduction of Zarzio. It is a version of Amgen’s Neupogen (filgrastim), which boosts white blood cells in patients who have undergone chemotherapy. Novartis priced Zarzio at a 15% discount to Neupogen.