Specialty Pharma Journal Specialty, Precision & Technology
Holzkirchen, Germany, October 31, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, HyrimozTM (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years …
Tag Archives: sandoz
November, 2018
September, 2018
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28 September
FDA Approves Pediatric Dose of Sandoz’s Symjepi Injection
PRINCETON, N.J., Sept. 27, 2018 /PRNewswire/ — Sandoz Inc. today announced that the US Food and Drug Administration has approved SYMJEPI™ (epinephrine) 0.15 mg Injection for the emergency treatment of allergic reactions in children. Sandoz will distribute and commercialize SYMJEPI™ (epinephrine) 0.15 mg Injection, as well as SYMJEPI 0.3 mg …
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 …
May, 2018
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3 May
Sandoz Receives Complete Response Letter from the FDA for Proposed Biosimilar Rituximab
Holzkirchen, May 2, 2018 – Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab. Sandoz stands behind the robust body of evidence included in the regulatory submission and …
January, 2018
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18 January
Sandoz Announces Exclusive Global Collaboration with Biocon on Next-Generation Biosimilars
Holzkirchen, 18 January 2018 – Sandoz, a Novartis division and the global leader in biosimilars, today announced a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility …
December, 2017
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8 December
New Phase 1 Data Shows Sandoz’s Proposed Biosimilar Pegfilgrastim Matches Reference Medicine
HOLZKIRCHEN, Germany, Dec. 8, 2017 /PRNewswire/ — Sandoz, a division of Novartis and the global leader in biosimilars, today announced data demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta®*1. The Phase I study, conducted in healthy volunteers, confirmed …
September, 2017
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13 September
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 …
March, 2017
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6 March
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 …
December, 2016
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5 December
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 …
August, 2016
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31 August
FDA Approves Sandoz’s Erelzi, a Biosimilar to Enbrel
Holzkirchen, August 30, 2016 – Sandoz, a Novartis division and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) approved Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) …