17, 2015 /PRNewswire/ -- Decision Resources Group finds that the majority of German patients receiving an infliximab biosimilar were biologic-naive and would have received Remicade
or another biologic if they had not received a biosimilar, according to surveyed German rheumatologists and gastroenterologists.
today announced that the Marketing Authorization Application (MAA) for SB2, its Remicade
(Infliximab) biosimilar candidate, has been submitted to the European Medicines Agency (EMA).
Epirus newly finished a successful Phase 3 trial which met its predefined endpoint, representing comparability of BOW015 to Remicade
as measured by ACR20 response in harsh rheumatoid arthritis (RA) patients.
At issue is whether Merck's $41 billion acquisition of Schering-Plough last year constituted a "change of control" at Schering that would cede the lucrative overseas Remicade
and Simponi rights back to J&J, which owns the drugs and sells them in the United States.
When used in combination with Methotrexate, Remicade
achieves the maximum clinical effect by stopping joint destruction.
Special Considerations: The risk of serious infections such as TB, sepsis, and pneumonia, is increased with Remicade
, as with other TNF blockers.
announced today that REMICADE
[R] (infliximab) has been approved by the FDA for the treatment of ulcerative colitis (UC), making REMICADE
the first and only biologic approved for UC, a chronic inflammatory bowel disease (IBD).
WASHINGTON - Patients taking Remicade
for rheumatoid arthritis suffered a type of cancer, lymphoma, at three times the rate of the general public, manufacturer Centocor warned doctors Thursday.
Two patients died of disseminated infections, but the relationship to Remicade
was unknown, according to the drug's labeling.
is a chimeric IgG1 mAb anti-TNF inhibitor.
(infliximab) was originally developed as a result of a collaboration between two professors at NYU Langone Medical Center and Centocor Ortho Biotech (acquired by Janssen Biotech, a subsidiary of J&J) (NYU Langone Medical Center, press release, August 12, 2005).
The launch of Remicade
biosimilar in Dec-2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than U.