Workflow
Humira (adalimumab)
icon
Search documents
Alvotech Announces Positive Top-Line Results from Pivotal Pharmacokinetic Study for Proposed Biosimilar to Entyvio®
Globenewswire· 2026-02-05 08:00
Core Insights - Alvotech announced positive top-line results from a pharmacokinetic study for AVT80, a biosimilar candidate to Entyvio, meeting all primary endpoints [1][2][3] Group 1: Study Details - The pharmacokinetic study (AVT80-GL-P01) was a randomized, double-blind, single-dose, parallel-group design involving healthy adult participants, demonstrating PK similarity and investigating safety, tolerability, and immunogenicity profiles of AVT80 compared to Entyvio after a single 108 mg/0.68 mL subcutaneous injection [2][4] - The study results are pivotal for supporting the demonstration of clinical similarity for both AVT16 and AVT80, which are proposed biosimilars to Entyvio for intravenous and subcutaneous administration, respectively [4] Group 2: Company Overview - Alvotech is a biotechnology company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates targeting various diseases [8] - The company has already approved and marketed two biosimilars, Humira and Stelara, in multiple global markets and has formed strategic commercial partnerships to enhance its global reach [8] Group 3: Market Context - Entyvio (vedolizumab) is indicated for treating moderate to severe Ulcerative Colitis and Crohn's disease, with combined net revenues from its sales reaching approximately US$6.4 billion in 2025 [5][6]
Global Markets React to Defense Deals, Pharma Breakthroughs, and Economic Indicators
Stock Market News· 2025-10-20 20:08
Defense Sector - General Dynamics has secured a €3.5 billion contract from the German Bundeswehr for the development and procurement of 274 reconnaissance vehicles, part of a larger €7 billion defense initiative to modernize Germany's military fleet, with deliveries expected to start in 2028 [2][9] - The overall defense package includes an additional €3.4 billion for 150 "Schakal" wheeled armored infantry fighting vehicles from Artec GmbH, with options to expand both orders [2][9] Pharmaceutical Sector - AbbVie announced positive topline results from its SELECT-SWITCH Phase 3b/4 study, showing that its arthritis drug Rinvoq (upadacitinib) is superior to Humira (adalimumab) in treating moderate to severe rheumatoid arthritis, with 43.3% of Rinvoq patients achieving low disease activity compared to 22.4% for Humira [3][9] Economic Outlook - The Bank of Canada reported subdued business confidence due to the impact of U.S. tariffs, with 33% of businesses and 64.1% of consumers anticipating a recession within the next year, which may lead to a potential interest rate cut [4][9] Artificial Intelligence Sector - AI startup Cohere, backed by Nvidia, is facilitating a secondary share sale for employees ahead of a potential IPO, recently valued at approximately $7 billion, with annualized revenue reported at $150 million [5][9] Technology Sector - Google is launching a "Trusted Tester" program for upcoming Pixel phones, selecting 15 "Superfans" to test unreleased devices and provide feedback, marking a shift in its pre-release strategy [6][9] Fiscal Policy - Brazil's Finance Minister stated that the government is on track to achieve the best fiscal result since 2015, attributing deficit reduction to efforts in cutting business subsidies [7][9]