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Biosimilars

FDA Approves Amgen and Allergan’s Mvasi for the Treatment of Five Types of Cancer

THOUSAND OAKS, Calif., Sept. 14, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin® (bevacizumab). MVASI is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the FDA. MVASI is …

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FDA Accepts for Review Sandoz’s BLA for Proposed Biosimilar Rituximab

Holzkirchen, September 12, 2017 – Sandoz, a Novartis Division, and the pioneer and 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 a proposed biosimilar to the reference medicine, Rituxan®** (rituximab). Rituxan®** is used to …

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Samsung, Biogen Biosimilar Version of AbbVie’s Humira Approved in the European Union

ZUG, Switzerland–(BUSINESS WIRE)–The European Commission (EC) granted a marketing authorization for IMRALDI® (also known as SB5), an adalimumab biosimilar referencing Humira®.1 IMRALDI has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ, BIIB) and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, …

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Biosimilars Forum Applauds Senator Passage of the FDA Reauthorization Act

Washington, D.C. (August 3, 2017) – Today, the Biosimilars Forum issued the following statement on passage of the Food and Drug Administration Reauthorization Act (FDARA): “The Biosimilars Forum applauds Senate passage of the FDA Reauthorization Act. This legislation provides the agency with the resources it needs to effectively and efficiently …

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FDA to Review Teva and Celltrion’s BLA for Proposed Biosimilar to Herceptin

INCHEON, Republic of Korea & JERUSALEM–(BUSINESS WIRE)–Jul. 31, 2017– Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P6, a proposed Monoclonal Antibody (mAb) biosimilar to Herceptin®1 (INN: trastuzumab) which is used for the treatment of Human Epidermal …

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Pfizer Announces Positive Top-Line Results from Comparative Study for PF-06439535, a Potential Biosimilar to Avastin

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin® (bevacizumab), met its primary objective. PF-06439535 is being developed by Pfizer as a potential biosimilar to Avastin. The trial demonstrated equivalence in the primary endpoint of objective …

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FDA Committee Recommends Approval of Mylan and Biocon’s Proposed Biosimilar Trastuzumab

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, July 13, 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) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible …

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Celltrion and Teva Announce FDA Acceptance of BLA for Proposed Biosimilar to Rituxan

INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc., a global biopharmaceutical company, and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P10, a proposed Monoclonal Antibody (mAb) biosimilar to Rituxan®1 (rituximab), …

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FDA Rejects Pfizer’s BLA for Proposed Epoetin Alfa Biosimilar

NEW YORK, N.Y., June 22 – Pfizer Inc. (NYSE:PFE) today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar. This CRL relates to matters noted in …

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Results from Late-Stage Study Demonstrate Clinical Equivalence of Boehringer Ingelheim’s Adalimumab Biosimilar Candidate to Humira

Ingelheim/Germany and Madrid/Spain, June 14, 2017 – Boehringer Ingelheim announced today results from the pivotal Phase III VOLTAIRE®-RA1  study, confirming that its adalimumab biosimilar candidate BI 695501 and HUMIRA®* have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis. The 24 week results will be presented at …

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