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.
SP and Merck noted that J&J's position is contradicted by the plain language of the Remicade
Humira and Remicade
are known as monoclonal antibodies and have been hailed as "smart bombs" because of their ability to attack diseases directly.
(infliximab) has been authorised in the EU since 1999 and recorded European sales of almost EUR2bn in 2013.
Painkillers, such as Teva Pharmaceutical Industries Ltd.'s generic oxycodone, and drugs that alter the immune system, including Johnson & Johnson's (New Brunswick NJ) Remicade
, were linked to a disproportionate number of deaths, which almost tripled in 2005 compared with 1998.
The approval was based on results from a Phase III randomised, double-blind trial, where Inflectra achieved the primary goal of therapeutic equivalence to the reference product, Remicade
MacKay said, 'Our US office will facilitate engagement with North American customers for our off-the-shelf biosimilar biological characterisation assays, for example for Humira, Enbrel, Rituxan, Herceptin, Remicade
, and Avastin.'
Schering-Plough, which also sells respiratory treatments and Remicade
for inflammatory disorders such as rheumatoid arthritis, posted net income of $543 million, or 36 cents per share, up from $350 million, or 24 cents, a year earlier.
M2 EQUITYBITES-January 23, 2012-MSD's Remicade
receives positive opinion from CHMP in Europe for treatment of ulcerative colitis in paediatric patients(C)2012 M2 COMMUNICATIONS http://www.m2.com
The company was founded by Sir Marc Feldmann of Oxford and Lawrence Steinman of Stanford, who have significant expertise in developing successful therapeutics that resulted in billion-dollar markets, including blockbusters like Johnson & Johnson (NYSE:JNJ)'s Remicade
Fahad Al-Najjar told KUNA that Stelara treatment is considered the latest medicine which was approved by the American Medical Association to maintain Crohn's disease stability, after the failure of Remicade
(infliximab) and Humira (adalimumab) with some cases.