Tag Archives: etanercept

October, 2018

24 October
Study Finds Enbrel Monotherapy and Combination Therapy Both Superior to Methotrexate in Patients with Psoriatic Arthritis

THOUSAND OAKS, Calif., Oct. 24, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that positive results from the Phase 3 SEAM-PsA study comparing the efficacy of Enbrel® (etanercept) monotherapy and ENBREL plus methotrexate to methotrexate monotherapy in patients with psoriatic arthritis (PsA) were presented in a late-breaking poster session at the 2018 American College of Rheumatology (ACR)/Association of …
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15 June
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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7 November
FDA Expands Approval of Enbrel for Use in Children with Plaque Psoriasis

THOUSAND OAKS, Calif., Nov. 4, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of ENBREL® (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque …
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8 July
Sandoz’s Enbrel Biosimilar Succeeds in Psoriasis Trial

Holzkirchen, July 7, 2016 – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met. The study compared …
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19 January
Biogen-Samsung’s Enbrel Biosimilar Wins European Approval

ZUG, Switzerland–(BUSINESS WIRE)–The joint venture between Biogen (NASDAQ:BIIB) and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for BENEPALI® , an etanercept biosimilar referencing Enbrel®i. BENEPALI has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis …
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11 January
Baxalta and Coherus’ Enbrel Biosimilar Meets Primary Endpoint in Late-Stage Study

REDWOOD CITY, Calif., and BANNOCKBURN, Ill., Jan. 11, 2016 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ:CHRS) and Baxalta Incorporated (NYSE:BXLT) today announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients …
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5 October
FDA Accepts Sandoz’s BLA for Biosimilar Etanercept

Holzkirchen, October 2, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel®* (etanercept) – a tumor necrosis factor …
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