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Rheumatoid Arthritis

Phase 3 Data of Amgen’s Infliximab Biosimilar Candidate Confirm Non-Inferiority

THOUSAND OAKS, Calif., June 27, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with REMICADE®(infliximab) in patients with moderate-to-severe rheumatoid arthritis. The results confirm non-inferiority compared to infliximab but could not rule out superiority based on its primary …

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Sandoz Presents New Long-Term and Switching Data for Biosimilars Zessly and Erelzi in Rheumatoid Arthritis

Holzkirchen, June 15, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced the presentation of two long-term, Phase III studies: one each for biosimilar Zessly®(infliximab)[4],[5] and biosimilar Erelzi® (etanercept).[6],[7] Research from the 54-week REFLECTIONS B537-02 study of Zessly and the 48-week EQUIRA study of Erelzi …

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Samsung Bioepis and Biogen Announce Pooled Analysis Results of Anti-TNF Biosimilars BENEPALI, FLIXABI and IMRALDI

INCHEON, Korea & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. and Biogen (Nasdaq:BIIB) today announced pooled analysis results of three anti-tumor necrosis factor (anti-TNF) biosimilars – BENEPALI™ (SB4, etanercept biosimilar), FLIXABI™ (SB2, infliximab biosimilar), and IMRALDI™ (SB5, adalimumab biosimilar) – which will be presented at the Annual European Congress of Rheumatology (EULAR 2018) …

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Celltrion Showcases Promising Preliminary Results for New Subcutaneous Formulation of CT-P13 in Rheumatoid Arthritis

AMSTERDAM–(BUSINESS WIRE)–New data presented at the Annual European Congress of Rheumatology (EULAR 2018) show that the subcutaneous (SC) formulation of CT-P13 is comparable in terms of efficacy and safety with the intravenous (IV) formulation of CT-P13 for the treatment of patients with rheumatoid arthritis (RA) up to week 30. The …

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AbbVie’s Upadacitinib Meets All Primary and Ranked Secondary Endpoints in a Phase 3 Rheumatoid Arthritis Study

NORTH CHICAGO, Ill., June 5, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from SELECT-EARLY showing that both doses of upadacitinib monotherapy (15 mg and 30 mg) met the primary endpoints of ACR50a at week 12 and clinical remissionb at week 24 versus methotrexate (MTX).1 Additionally, all ranked …

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FDA Approves Olumiant for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis

INDIANAPOLIS, June 1, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation(NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT® (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or …

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Gilead and Verily Announce Scientific Collaboration to Identify and Understand Immunological and Molecular Drivers of Inflammatory Diseases

FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Verily Life Sciences LLC, an Alphabet company, today announced a scientific collaboration using Verily’s Immunoscape platform to identify and better understand the immunological basis of three common and serious inflammatory diseases: rheumatoid arthritis, inflammatory bowel disease …

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FDA Committee Recommends Approval of Baricitinib for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

INDIANAPOLIS, April 23, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis …

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AbbVie’s Upadacitinib Meets All Primary and Secondary Endpoints in Late-Stage Rheumatoid Arthritis Study

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing study evaluated upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to …

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FDA Approves Pfizer’s Ixifi, a Biosimilar to Remicade

Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved IXIFI as …

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