Tag Archives: adalimumab

September, 2018

27 September
Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the FDA

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. …
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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 …
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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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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 …
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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 …
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26 September
FDA Approves Amgen’s Humira Biosimilar for Treatment of Seven Inflammatory Diseases

THOUSAND OAKS, Calif., Sept. 23, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment …
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12 July
First Amgen Biosimilar Candidate & Adalimumab Biosimilar Candidate to be Reviewed by FDA Committee

THOUSAND OAKS, Calif., July 12, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira® (adalimumab), an anti-tumor necrosis factor-alpha (TNF-α) …
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1 July
AbbVie’s Humira Gains FDA Approval to Treat Patients with Certain Types of Uveitis

NORTH CHICAGO, Ill., June 30, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. HUMIRA is now the first and only FDA-approved non-corticosteroid therapy available for …
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15 June
FDA Panel Scheduled to Review Amgen’s Humira Biosimilar

THOUSAND OAKS, Calif., June 13, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Company’s Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab). “With our heritage in both rheumatology …
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11 March
Regeneron and Sanofi’s RA Drug Meets Primary Endpoint in Late-Stage Trial

TARRYTOWN, N.Y. and PARIS, March 11, 2016 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Phase 3 monotherapy study met its primary endpoint demonstrating that sarilumab was superior to adalimumab (marketed by AbbVie as HUMIRA®) in improving signs and symptoms in patients with active rheumatoid arthritis …
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