Specialty Pharma Journal Specialty, Precision & Technology
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 …
Tag Archives: infliximab
June, 2018
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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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13 June
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 …
April, 2017
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26 April
Samsung Bioepis’ Biosimilar Version of Remicade Receives FDA Approval
INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, RENFLEXIS™ is indicated for reducing signs and symptoms in patients with adult and …
January, 2017
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18 January
Facing Down Crohn’s and Related Diseases
Inflammatory bowel disease – which includes both Crohn’s disease and ulcerative colitis – affects 1.6 million Americans, a number that continues to rise. Each year, the U.S. sees 70,000 new cases diagnosed. Although a cure remains elusive, these chronic and life-long diseases can be treated with a variety of treatment …
September, 2016
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19 September
Pfizer’s Remicade Biosimilar Candidate Succeeds in Late-Stage Study
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced the confirmatory study (REFLECTIONS B537-02) evaluating the efficacy, safety, and immunogenicity of PF-06438179 (infliximab-Pfizer) compared to Remicade® (infliximab) met its primary endpoint. The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology …
April, 2016
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5 April
FDA Approves Celltrion’s Inflectra, a Biosimilar to Remicade
The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by …
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4 April
Samsung Bioepis’ Infliximab Biosimilar Recommended for Approval in the European Union
INCHEON, Korea – April 1, 2016 – Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Flixabi® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of …
March, 2016
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18 March
Studies Show Comparable Efficacy and Safety after Switching from Remsima from Originator
AMSTERDAM–(BUSINESS WIRE)–Real-world studies with nearly 600 inflammatory bowel disease (IBD) patients in eight countries show comparable efficacy and safety following a switch to biosimilar infliximab from originator infliximab.1-10 These studies, presented at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO), further support the appropriate switching of patients …
February, 2016
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12 February
Sandoz Acquires Rights to Pfizer’s Biosimilar Infliximab in EEA
Holzkirchen, 12 February, 2016 – Sandoz, a Novartis company and a global leader in biosimilars, announced today that it has acquired from Pfizer the rights for the development and commercialization of PF-06438179 (biosimilar infliximab) in the 28 countries that form the European Economic Area (EEA)*. Infliximab is a tumor necrosis …