MedPath

Tagged News

Alvotech Secures Japanese Approval for Three Biosimilars Including First Global Golimumab Biosimilar

Drug ApprovalMonoclonal AntibodyOncology
  • Alvotech's partner Fuji Pharma received Japanese regulatory approval for three biosimilars: AVT03 (denosumab), AVT05 (golimumab), and AVT06 (aflibercept) from the Ministry of Health, Labor and Welfare.
  • AVT05 represents the first golimumab biosimilar approved for sale in major global markets, marking a significant milestone in biosimilar development.
  • The approvals expand treatment access for multiple conditions including bone lesions, rheumatoid arthritis, and various eye disorders in the Japanese market.
  • This achievement builds on Alvotech and Fuji Pharma's successful partnership, which previously launched Japan's first Stelara biosimilar in May 2024.

Landmark Clinical Trials Demonstrate Efficacy of IL-13 and IL-4/IL-13 Inhibitors in Patients with Darker Skin Tones

Monoclonal Antibody
  • The ADmirable trial showed that nearly 70% of patients with moderate to severe atopic dermatitis and Fitzpatrick skin types IV-VI achieved at least 75% improvement with lebrikizumab treatment over 16 weeks.
  • The DISCOVER study demonstrated that more than 70% of patients with skin of color, including over 80% African American participants, achieved EASI-75 response with dupilumab treatment over 24 weeks.
  • Both trials revealed safety profiles in patients with skin of color that were comparable to those observed in original pivotal phase 3 studies, addressing historical gaps in clinical trial representation.
  • These studies represent a paradigm shift by intentionally enrolling patients with darker skin tones and evaluating concerns specific to patients with skin of color, including postinflammatory pigmentation changes.

Chugai Receives Japanese Approval for Tecentriq in Rare Lymphoma, Marking First Checkpoint Inhibitor for ENKL

Drug ApprovalMonoclonal AntibodyRare Disease
  • Chugai Pharmaceutical obtained regulatory approval from Japan's Ministry of Health, Labour and Welfare for Tecentriq (atezolizumab) to treat relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (ENKL).
  • Tecentriq becomes the first immune checkpoint inhibitor approved in Japan for ENKL, a rare malignant lymphoma where approximately 60% of patients relapse after initial treatment with no established standard therapy after relapse.
  • The approval was based on results from the phase II ATTACK study conducted by Japanese investigators, including National Cancer Center Hospital, evaluating efficacy and safety in relapsed/refractory ENKL patients.
  • Chugai also received approval for a 4-weekly dosing regimen for existing lung cancer and breast cancer indications, providing more flexible treatment planning and reducing hospital visit burden.

Celltrion Launches First Omalizumab Biosimilar Omlyclo in Europe, Starting with Norway

Monoclonal Antibody
  • Celltrion has become the first pharmaceutical company to launch Omlyclo, an omalizumab biosimilar referencing Xolair, in the European market starting with Norway.
  • The biosimilar is approved for treating allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps across the EU.
  • Celltrion plans to expand Omlyclo to five additional European markets including Germany, Britain, Spain, France, and Italy to capture significant biosimilar market share.
  • The company's dermatology portfolio now includes five products and aims to commercialize 22 biosimilars by 2030 as the global biosimilar market is projected to reach 261 trillion won.

Merck Invests €150 Million in Advanced Filtration Manufacturing Facility in Ireland

Monoclonal Antibody
  • Merck has opened a €150 million, 3,000-square-meter cleanroom facility in Blarney, Cork, to manufacture advanced filtration products for vaccines, monoclonal antibodies, and cell and gene therapies.
  • The facility is part of Merck's largest Life Science investment in Ireland totaling €440 million across Cork operations, expected to create over 200 new jobs by 2028.
  • Production is scheduled to begin in Q4 2025, focusing on filtration devices for aseptic processing, tangential-flow filtration, and virus filtration technologies.
  • The investment represents part of Merck's €2 billion global Life Science expansion program launched in 2020 to meet growing demand for life-saving therapies.

Argenx Expands Partnership with Fujifilm Biotechnologies to Manufacture Efgartigimod in the U.S.

Monoclonal Antibody
  • Argenx has expanded its strategic partnership with Fujifilm Biotechnologies to initiate manufacturing of efgartigimod drug substance at the Holly Springs, North Carolina site beginning in 2028.
  • The collaboration marks Fujifilm Biotechnologies' first global end-to-end program utilizing its kojoX modular network, providing local-for-local supply across the U.S., U.K., Denmark, and Japan.
  • Efgartigimod is a monoclonal antibody fragment targeting the neonatal Fc receptor, approved globally for treating generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
  • The partnership will strengthen supply chain resilience and enable manufacturing medicines in the U.S. for American patients while supporting broader global reach.

Wheeler Bio Partners with MindImmune to Advance First-in-Class Alzheimer's Therapy MITI-101

Monoclonal Antibody
  • Wheeler Bio has entered into a CDMO partnership agreement with MindImmune Therapeutics to support the development of MITI-101, a first-in-class monoclonal antibody for Alzheimer's disease treatment.
  • MITI-101 is designed to block CD11c+ immune cell recruitment from blood into the brain, targeting neuroinflammation believed to underlie Alzheimer's and other neurodegenerative disorders.
  • The partnership will utilize Wheeler Bio's ModularCMC platform to provide integrated process development and cGMP drug substance manufacturing services to advance MITI-101 toward clinical trials.
  • This collaboration represents a novel therapeutic approach addressing significant unmet medical need in Alzheimer's disease by preventing harmful immune cell infiltration into the brain.

Regeneron's Garetosmab Achieves 90% Reduction in Bone Formation in Rare Disease Trial

Monoclonal AntibodyRare DiseaseOrphan Drug
  • Regeneron's Phase 3 OPTIMA trial of garetosmab met its primary endpoint, demonstrating a 90% or greater reduction in new heterotopic ossification lesions in adults with fibrodysplasia ossificans progressiva at 56 weeks.
  • The monoclonal antibody targeting activin A achieved over 99% reduction in total volume of new bone lesions, with the Independent Data Monitoring Committee recommending placebo patients transition to active treatment.
  • The company plans to submit garetosmab for U.S. regulatory approval by the end of 2025, positioning it as a potential first-in-class therapy for this ultra-rare genetic disorder affecting fewer than 1 in 2 million individuals.

LEO Pharma's Temtokibart Meets Primary Endpoint in Phase 2b Atopic Dermatitis Trial

Monoclonal Antibody
  • LEO Pharma's investigational monoclonal antibody temtokibart met its primary endpoint in a Phase 2b trial, demonstrating significant improvements in EASI scores for three highest doses in moderate-to-severe atopic dermatitis patients.
  • The drug showed rapid onset of action with significant improvements observed as early as Week 1 for some doses, and sustained efficacy maintained up to Week 32 despite treatment cessation at Week 14.
  • Biomarker analysis revealed 97% improvement in immune gene expression by Week 16, with strong correlations between clinical improvements and dampening of key immune pathways.
  • Temtokibart demonstrated a favorable safety profile with no dose-dependent adverse events, low conjunctivitis incidence, and no herpes signal in the 262-patient study.

Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis

NCT06585202CompletedPhase 2
Aclaris Therapeutics, Inc.
Posted 8/19/2024

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis

NCT05923099CompletedPhase 2
LEO Pharma
Posted 9/20/2023

AstraZeneca's Saphnelo Subcutaneous Formulation Meets Primary Endpoint in Phase III Lupus Trial

Monoclonal Antibody
  • AstraZeneca's subcutaneous formulation of Saphnelo (anifrolumab) demonstrated statistically significant and clinically meaningful reduction in disease activity compared to placebo in the Phase III TULIP-SC trial for systemic lupus erythematosus.
  • The interim analysis of 220 patients showed the subcutaneous administration maintained the same safety profile as the approved intravenous formulation while offering greater convenience for self-administration.
  • The positive results could expand access to this first-in-class type I interferon receptor antagonist, as approximately half of lupus patients currently taking biologics already use self-administered subcutaneous options.
  • Results will be presented at the American College of Rheumatology Convergence 2025 meeting and are under regulatory review for potential approval of the new administration route.

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

NCT04877691Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/8/2021

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

NCT05138133RecruitingPhase 3
AstraZeneca
Posted 2/15/2022

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

NCT06015737RecruitingPhase 3
AstraZeneca
Posted 6/29/2024

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

NCT02446912CompletedPhase 3
AstraZeneca
Posted 6/9/2015

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

NCT01438489CompletedPhase 2
MedImmune LLC
Posted 1/1/2012

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

NCT05925803RecruitingPhase 3
AstraZeneca
Posted 11/8/2023

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

NCT02446899CompletedPhase 3
AstraZeneca
Posted 7/9/2015

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

NCT06455449RecruitingPhase 3
AstraZeneca
Posted 6/20/2024

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.