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 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 a related condition called
ankylosing spondylitis.
Moreover, the panel agreed Remsima is likely as safe and effective
for other conditions Remicade treats, including psoriasis and
inflammatory bowel conditions like 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 irritable bowel disease
before assuming that the medicines are similar in those conditions.
"Only direct clinical comparisons of (Remsima) and Remicade in
active irritable 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 United States
by 2018 and wrest sales from Remicade as well as from AbbVie's
Humira and Amgen's Enbrel, which also block the inflammation-causing
protein tumor necrosis factor.
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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, which boosts white blood cells in
patients who have undergone chemotherapy. Novartis priced Zarzio at
a 15 percent discount to Neupogen.
(Reporting by Ransdell Pierson in New York; Editing by Bernard Orr
and Matthew Lewis)
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