Ulcerative Colitis

Pfizer’s Xeljanz Demonstrates Positive Results in its Late-Stage Ulcerative Colitis Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated …

Read More »

Brazil Approves Hospira’s Remsima, a Biosimilar Version of Remicade

The National Health Surveillance Agency in Brazil, ANVISA, has approved the first biosimilars monoclonal antibody for use in the country. Leading biosimilars drugmaker Hospira, Inc. announced that its partner Celltrion has received approval for its Remsima (infliximab) for use in Brazil. The drug is the first biological medication approved by …

Read More »

Biogen’s Biosimilar Version of Remicade Accepted for Review by EMA

Biogen recently announced that European health regulators have accepted its biosimilar version of Remicade for review. The company said that the Marketing Authorization Application (MAA) for SB2, its biosimilar infliximab candidate using Remicade as a reference product, has been validated for review by the European Medicines Agency (EMA). The application …

Read More »

Samsung Submits Application to the EMA for its Remicade Biosimilar Candidate, SB2

South Korea’s Samsung Bioepis Co., Ltd. recently announced that it has submitted a marketing authorization application (MAA) for SB2, its Remicade (infliximab) biosimilar candidate to European health regulators. The company said that it has submitted the MAA to the European Medicines Agency (EMA). The MAA for SB2 is the second …

Read More »