Specialty Pharma Journal Specialty, Precision & Technology
INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB5, a biosimilar candidate referencing HUMIRA® i (adalimumab). The BLA for SB5 was submitted by Samsung Bioepis in July 2018. …
Tag Archives: Humira
September, 2018
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12 September
Biosimilar Cyltezo Demonstrates Clinical Equivalence to Humira in Patients with Moderate-to-Severe Plaque Psoriasis
RIDGEFIELD, Conn., Sept. 12, 2018 /PRNewswire/ — Boehringer Ingelheim today announced results from a phase III study, confirming that Cyltezo® is equivalent to Humira®*, with no clinically meaningful differences in efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis.1 The 16-week data was presented at the European Association …
August, 2017
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25 August
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, …
June, 2017
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16 June
Pfizer Announces Results from Xeljanz ORAL Strategy Study in Patients with Rheumatoid Arthritis
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today detailed results from ORAL Strategy, a head-to-head, noninferiority Phase 3b/4 study of XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) as monotherapy or in combination with methotrexate (MTX) compared to Humira® plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). …
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14 June
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 …
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 …
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3 March
Janssen’s Guselkumab Succeeds in Two Late-Stage Studies in Patients with Moderate-to-Severe Psoriasis
ORLANDO, Fla.–(BUSINESS WIRE)–Janssen Research & Development, LLC (Janssen) announced today new findings from two pivotal Phase 3 studies reporting the efficacy and safety of guselkumab in the treatment of adults with moderate to severe plaque psoriasis.1–3 Data from the VOYAGE 2 study showed that patients treated with guselkumab experienced significant …
February, 2017
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17 February
Pfizer Announces Top-Line Results from the Oral Strategy Trial of Xeljanz Compared to Humira
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ® (tofacitinib citrate) 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination …
January, 2017
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18 January
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 …
November, 2016
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30 November
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 …