The company manufactures Remicade
, a therapy that combats Crohn's disease and rheumatoid arthritis.
notes that over 400,000 patients have been treated with Remicade
since its approval nearly five years ago by the Food and Drug Administration.
the company said that CHMPs recommendation of Flixabi was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Flixabi compared to Remicade
on a total of 584 randomized patients with moderate to severe rheumatoid arthritis.
6,284,471 ('471) relating to REMICADE
This indication further solidifies the role Remicade
plays in the treatment of Crohn's disease, particularly among those struggling with fistulas," comments Jerome Boscia, vice president of clinical research and development for Centocor, which has exclusive marketing rights for Remicade
in the United States.
, Enbrel and Humira are all administered via injection.
In China, Remicade
is not included in the current NRDL (National Reimbursement Drugs List) although it is included in select PRDLs (Provincial Reimbursement Drugs List), and, currently, one year treatment of CD with Remicade
costs around $14,000 (in U.
Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, has submitted a marketing authorisation application seeking approval for its Remicade
(Infliximab) biosimilar candidate, SB2 to the European Medicines Agency, it was reported yesterday.
Amgen is also anticipating a psoriasis indication for Enbrel, as are J&J for Remicade
and Genentech for Raptiva.
However, because many MCOs already cover Janssen Biotech's Remicade
and Abbott's Humira on tier 2, emerging therapies will face challenges obtaining preferential coverage.
The major European markets can finally benefit from the availability of Inflectra following the patent expiry of reference product Remicade
Meanwhile, Johnson & Johnson is boosting its sales operation to maintain its market-leading role for Remicade
, an RA treatment that has been available since 1999.
Johnson & Johnson's Remicade
has garnered strength amid Enbrel's paltry production levels.
Clinical data and the opinions of interviewed thought leaders indicate that key current and emerging therapies have no advantage on this attribute over Janssen Biotech/Merck/Mitsubishi Tanabe's Remicade
, the sales leading agent for Crohn's disease.
The company got its final marketing and manufacturing approval in India for a generic version of the rheumatoid arthritis drug, Remicade