Samsung Bioepis: Final European Approval for Remicade CopySamsung Bioepis: Final European Approval for Remicade Copy
South Korea's Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson's blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. International Approvals (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 31, 2016 Category: Consumer Health News Tags: Rheumatology News Alert Source Type: news
FLIXABI(R), Biogens Infliximab Biosimilar Referencing Remicade(R), Approved in the European Union
Biogen to manufacture and commercialize FLIXABI, the companys second anti-TNF biosimilar therapy in the EU
ZUG, Switzerland--(Healthcare Sales & Marketing Network)--The European Commission (EC) today granted marketing authorization in the European Unio... Biopharmaceuticals, RegulatoryBiogen, FLIXABI, biosimilar, Remicade (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 30, 2016 Category: Pharmaceuticals Source Type: news
Samsung Bioepis receives final European approval for its Remicade copy
SEOUL (Reuters) - South Korea's Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson's blockbuster rheumatoid arthritis drug Remicade has received final approval from European regulators, paving the way for its second product launch in Europe. (Source: Reuters: Health)
Source: Reuters: Health - May 30, 2016 Category: Consumer Health News Tags: healthNews Source Type: news
Pregnancy alters pharmacodynamics of infliximab, adalimumab in women with IBD
SAN DIEGO – Blood levels of infliximab rose during pregnancy, while adalimumab levels remained stable, even after researchers accounted for changes in albumin, body mass index, and C-reactive protein... (Source: Family Practice News)
Source: Family Practice News - May 24, 2016 Category: Primary Care Source Type: news
Merck Announces FDA Accepts Samsung Bioepis’ Biologics License Application (BLA) for SB2 (Infliximab), an Investigational Biosimilar of Remicade
Dateline City:
KENILWORTH, N.J.
First BLA Filed by Samsung Bioepis as Part of Its Partnership with Merck
KENILWORTH, N.J. – Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade.
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Source: Merck.com - Corporate News - May 23, 2016 Category: Pharmaceuticals Tags: Corporate News Latest News Source Type: news
Samsung Bioepis applies for approval to sell Remicade biosimilar in U.S.
SEOUL (Reuters) - South Korean biosimilars maker Samsung Bioepis Co Ltd said on Tuesday it has applied to the U.S. Food and Drug Administration (FDA) for approval to sell its version of blockbuster drug Remicade in the world's biggest healthcare market. (Source: Reuters: Health)
Source: Reuters: Health - May 23, 2016 Category: Consumer Health News Tags: healthNews Source Type: news
Samsung Targets U.S. Drug Market With Remicade Knockoff
Samsung Group said its near-replica of Johnson & Johnson’s blockbuster arthritis drug Remicade has been accepted for review by the U.S. Food and Drug Administration. (Source: WSJ.com: Health)
Source: WSJ.com: Health - May 23, 2016 Category: Pharmaceuticals Tags: PAID Source Type: news
Merck Announces FDA Accepts Samsung Bioepis’ BLA for SB2 (infliximab), an Investigational Biosimilar of Remicade
KENILWORTH, N.J., May 23, 2016 – Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 23, 2016 Category: Drugs & Pharmacology Source Type: news
Merck sales disappoint as Januvia, Remicade fall short
(Reuters) - Merck & Co Inc on Thursday reported lower-than-expected quarterly revenue, hurt by disappointing sales of its Januvia diabetes treatment and Remicade arthritis drug. (Source: Reuters: Health)
Source: Reuters: Health - May 5, 2016 Category: Consumer Health News Tags: healthNews Source Type: news
Real-World Success Seen With Infliximab Biosimilar (CME/CE)
(MedPage Today) -- Efficacy and safety similar to Remicade in two U.K. centers (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - May 3, 2016 Category: Primary Care Source Type: news
Mucosal Healing With Infliximab Biosimilar in Ulcerative ColitisMucosal Healing With Infliximab Biosimilar in Ulcerative Colitis
About two-thirds of patients with ulcerative colitis (UC) had mucosal healing by the end of induction treatment with the infliximab biosimilar CT-P13, according results of the first prospective study to evaluate this. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 2, 2016 Category: Consumer Health News Tags: Gastroenterology News Source Type: news
infliximab-dyyb (Inflectra)
Title: infliximab-dyyb (Inflectra)Category: MedicationsCreated: 4/25/2016 12:00:00 AMLast Editorial Review: 4/25/2016 12:00:00 AM (Source: MedicineNet Digestion General)
Source: MedicineNet Digestion General - April 25, 2016 Category: Nutrition Source Type: news
Inflectra (Infliximab-Dyyb Intravenous Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 19, 2016 Category: Drugs & Pharmacology Source Type: news
