FDA advisory panel strongly backs biosimilar Remicade

A medical advisory panel to the U.S. food and Drug management on Tuesday endorsed approval of a less expensive biosimilar form of Johnson & Johnson's Remicade arthritis drug that might eventually batter sales of the branded product.

The panel, through a vote of 21-3, supported use of the biosimilar from Celltrion Inc and Pfizer Inc, referred to as Remsima. The FDA generally, however no longer usually, follows the recommendation of its advisory panels.

The unbiased panel determined that scientific trials of Remsima showed no clinically full-size variations with Remicade in treatment of rheumatoid arthritis and a related situation referred to as ankylosing spondylitis.

moreover, the panel agreed Remsima is probable as safe and powerful for different situations Remicade treats, which include psoriasis and inflammatory bowel situations like Crohn's disease and ulcerative colitis, even though Remsima turned into now not examined against the ones situations.

earlier than the vote, Jay Siegel, J&J's chief biotechnology officer, entreated the panel to wait for results of an ongoing Celltrion look at evaluating Remsima and Remicade against inflammatory bowel ailment earlier than assuming that the drug treatments are similar in the ones situations. "only direct clinical comparisons of (Remsima) and Remicade in energetic inflammatory bowel disorder can offer the needful assurance," he stated.

but the FDA has previously decided it can be suitable to license biosimilars for additional situations for which a branded product is accredited, even though the biosimilar has no longer been tested for them.

Dr. Steven Solga, head of gastroenterology at St. Luke's college sanatorium in Bethlehem, Pennsylvania, informed the panel it makes no sense to require biosimilars to be examined for every circumstance because such trials could be too small to supply reliable effects.

a few analysts assume Remsima to be introduced in the america by using 2018 and wrest income from Remicade as well as from AbbVie's Humira and Amgen's Enbrel, which additionally block the irritation-causing protein tumor necrosis factor.

Celltrion and Pfizer have not disclosed what they may price for Remsima, however a extensive bargain from Remicade is expected.

stocks of J&J, AbbVie and Amgen fell sharply on Friday after FDA scientists issued a briefing paper backing Remsima. stocks of the drugmakers have been little changed after-hours on Tuesday.

Remsima could become the second one accepted biosimilar within the united states, following Novartis AG's September introduction of Zarzio. it's miles a model of Amgen's Neupogen, which reinforces white blood cells in patients who've undergone chemotherapy. Novartis priced Zarzio at a fifteen percentage discount to Neupogen.