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Biosimilars

New Data Demonstrate Sandoz Proposed Biosimilar Adalimumab has Equivalent Efficacy to Reference Medicine

Holzkirchen, 6 March 2017 – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today presented data for its proposed biosimilar adalimumab (GP2017). The Phase 3 confirmatory efficacy, safety and immunogenicity study met its primary endpoint demonstrating GP2017 has equivalent efficacy to the reference medicine, Humira®1. Results …

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FDA Accepts for Review Mylan’s Application for Proposed Biosimilar Pegfilgrastim

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Feb. 16, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta®  (pegfilgrastim), for filing through the …

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Aurobindo Pharma Acquires Four Biosimilar Products from TL Biopharmaceutical

Aurobindo Pharma Limited is pleased to announce the acquisition of four cell culture derived biosimilar products from TL Biopharmaceutical AG. As part of this agreement, TL will supply all the developmental data for four molecules and Aurobindo and/or its affiliates will develop, commercialize and market these products globally. The branded …

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FDA and EMA Accept Boehringer Ingelheim’s Biosimilar Candidate to Humira for Review

Ingelheim, Germany, January 18, 2017 – Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA). “We believe that if approved, BI 695501 can provide a valuable …

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Biosimilars Forum Statement Regarding FDA’s Final Guidance on Nonproprietary Naming of Biosimilars

Washington, DC, January 12, 2017 – The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States today issued the following statement regarding the Food and Drug Administration’s (FDA) final guidance for industry on nonproprietary naming of biological products. “The Biosimilars Forum appreciates …

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FDA Accepts Mylan and Biocon’s BLA for Proposed Biosimilar Trastuzumab

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Jan. 11, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through …

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Celltrion Presents Positive Results for its Cancer Biosimilar CT-P10

SAN DIEGO–(BUSINESS WIRE)–New data presented at the 2016 American Society of Hematology (ASH) Annual Meeting demonstrate that CT-P10 (biosimilar rituximab candidate) and reference rituximab are equivalent in terms of pharmacokinetics (PK) in patients with advanced follicular lymphoma (AFL), a form of non-Hodgkin lymphoma. 1 A total of 121 AFL patients …

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Sandoz Announces New Data on Proposed Biosimilar Rituximab

Holzkirchen, December 5, 2016 – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced data from the ASSIST-FL trial. The confirmatory safety and efficacy study shows GP2013 met its primary endpoint of overall response rate (ORR), demonstrating equivalence with the reference product, MabThera®*, in 629 …

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Momenta’s Humira Biosimilar Succeeds in Late-Stage Psoriasis Study

CAMBRIDGE, Mass., Nov. 29, 2016 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion …

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Pfizer’s Investigational Biosimilar to Herceptin Meets Primary Endpoint in Pivotal Trial

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of PF-05280014 versus Herceptin® (trastuzumab), met its primary endpoint. PF-05280014 is being developed by Pfizer as a potential biosimilar to Herceptin. The trial demonstrated equivalence in the primary endpoint of objective …

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