Avtozma (tocilizumab-anoh) / Celltrion - LARVOL DELTA

NRG-BN010: Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma (clinicaltrials.gov) - P2 | N=61 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2026 ➔ Aug 2027

Biomarker • Trial completion date • Astrocytoma • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • EGFR • MGMT • TERT

According to Celltrion on Monday, its autoimmune disease treatment Avtozma (tocilizumab) has been listed as a preferred drug on the private-insurance formularies of all three major US PBMs - Express Scripts, CVS Caremark and Optum (The Herald Business - Herald Corp) - "With Monday's announcement, the drug has secured a presence across all three major PBMs' private-insurance segments within roughly seven months of its US launch, giving it reimbursement coverage for more than half of the entire US insurance market. Patient reimbursement through Express Scripts and Optum took effect from the first quarter of this year, while CVS coverage began last month."

US reimbursement • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

Celltrion plans to launch Avtozma (tocilizumab) in a subcutaneous (SC) formulation and OMLYCLO (Omalizumab) in the United States in the second half (Chosun Biz)

Biosimilar launch • Allergy • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Food Hypersensitivity • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Rheumatoid Arthritis

A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) (clinicaltrials.gov) - P2/3 | N=340 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2029 ➔ Oct 2033 | Trial primary completion date: Feb 2029 ➔ Oct 2033

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

1438-0011: A study in people with advanced extrapulmonary neuroendocrine cancer to compare obrixtamig plus carboplatin and etoposide treatment with standard chemotherapy. (clinicaltrialsregister.eu) - P2/3 | N=74 | Not yet recruiting | Sponsor: Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

New P2/3 trial • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) (clinicaltrials.gov) - P2/3 | N=340 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) (clinicaltrials.gov) - P2/3 | N=340 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2/3 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Avtozma expected to enter the U.S. market this year (Korea Biomedical Review)

Launch US • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

Celltrion launches Avtozma in Japan, entering tocilizumab market as first mover (Korea Biomedical Review) - "Celltrion's Japanese subsidiary will commercialize Avtozma via a direct sales model, utilizing its established marketing expertise and supply capabilities to facilitate early market penetration."

Launch Japan • Immunology • Inflammation • Rheumatoid Arthritis

Celltrion grows Europe share as…autoimmune drugs win tenders, scripts (Chosun Biz) - "The autoimmune disease treatment 'Avtozma' (tocilizumab) was selected as a supplier in tenders for Spain's Basque and Madrid regions and in a tender by INGESA under the Ministry of Health. In Portugal, it secured the top-priority national tender supplier status for both the autoinjector and vial formulations. In Germany, sales of Avtozma are increasing....The expansion of Avtozma sales led to increased prescriptions of 'Yuflyma' (adalimumab). Since Abtozma's launch, Yuflyma has continued to grow about 10% per quarter."

Commercial • Ankylosing Spondylitis • Crohn's disease • Giant Cell Arteritis • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Celltrion announces U.S. availability of AVTOZMA (tocilizumab-anoh) subcutaneous (SC) formulation (The Manila Times) - "The SC formulation of AVTOZMA is indicated for the treatment of rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA). AVTOZMA SC is available in a 162 mg/0.9 mL solution for injection in a single-dose prefilled syringe or a single-dose prefilled autoinjector, allowing patients the flexibility and convenience of administering their treatment at home....Celltrion provides support to U.S. patients prescribed AVTOZMA through its patient support program, Celltrion CONNECT."

Biosimilar launch • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

…Celltrion's autoimmune disease therapies are also expanding their share in Japan (Chosun Biz) - "The infliximab biosimilar 'Remsima' holds a 43% share in Japan, while the adalimumab biosimilar 'Yuflyma' holds 17%....Celltrion...plans to launch the tocilizumab biosimilar 'Avtozma' in the second quarter of this year."

Biosimilar launch • Commercial • Ankylosing Spondylitis • Crohn's disease • Giant Cell Arteritis • Hidradenitis Suppurativa • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Celltrion launches biosimilar Avtozma in 3 European markets (Yonhap News Agency) - "The launches in Germany, Spain and France follow approvals last year from local authorities for both the intravenous (IV) and subcutaneous (SC) formulations of Avtozma, the company said in a press release. Celltrion said it plans to launch the drug in Britain and Italy as well."

Biosimilar launch • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

BLA 761420/S-005 (FDA) - "We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling."

FDA approval • Giant Cell Arteritis • Idiopathic Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis

Celltrion's biosimilar for autoimmune diseases, "Avtozma (ingredient name tocilizumab)," has been added to the formulary of Synergie Collective, one of the top five pharmacy benefit managers (PBMs) in the United States. (Chosun Biz) - "The product listed this time is the Avtozma intravenous (IV) formulation. It was designated as a 'preferred' drug on the formularies of all public and private insurers overseen by Synergie Collective."

Reimbursement • Rheumatoid Arthritis

Celltrion added that its newly approved rheumatoid arthritis drug Avtozma (tocilizumab), cleared by Japan’s Ministry of Health, Labour and Welfare last month, is scheduled for launch next year (Pulse by Maeil Business News Korea)

Launch Japan • Rheumatoid Arthritis

Celltrion's Avtozma Launches in the US...Insurance Companies' Formularies Listed [Google translation] - "According to the company, Avtozma was launched in the US at a high wholesale price (WAC), approximately 35% lower than the original drug....With Minnesota's listing progressing rapidly, the likelihood of Avtozma being adopted as a preferred drug in other BCBS states is expected to increase significantly. The company anticipates that Avtozma's listing will accelerate further, as negotiations are ongoing with major players, including BCBS and the three largest prescription drug benefit managers (PBMs) in the United States. "

Cytokine release syndrome • US reimbursement • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

Celltrion launches AVTOZMA (tocilizumab-anoh) intravenous (IV) formulation in the United States (PRNewswire) - "AVTOZMA IV is approved for all same indications as the reference product Actemra (tocilizumab), including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA), coronavirus disease (COVID-19) and cytokine release syndrome (CRS)....The available presentations are 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials."

Biosimilar launch • Cytokine release syndrome • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis

CT-P47/Tocilizumab-anoh: A Tocilizumab Biosimilar. (PubMed, Clin Drug Investig) - "The overall safety and immunogenicity profiles of CT-P47 were similar to those of reference tocilizumab, and switching from reference tocilizumab to CT-P47 did not affect safety or efficacy. The role of reference tocilizumab in the management of inflammatory diseases is well established and CT-P47 provides an effective biosimilar alternative for patients requiring tocilizumab therapy."

Journal • Review • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Novel Coronavirus Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Celltrion wins Japan approval for biosimilar AVTOZMA targeting autoimmune market (Chosun Biz) - "AVTOZMA secured approvals for the main indications (target disease groups) held by the original drug, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS). Celltrion plans to expedite the launch of AVTOZMA in Japan as a first-mover biosimilar and move quickly to expand its market share."

Cytokine release syndrome • Japan approval • Idiopathic Arthritis • Rheumatoid Arthritis

Celltrion, 'Avtozma' Phase 3 52-week results published in international academic journal [Google translation] (HIT News) - P3 | N=471 | NCT05489224 | Sponsor: Celltrion | "According to the company, this study contains the long-term results of a phase 3 clinical trial that evaluated the efficacy, pharmacokinetics, safety, and immunogenicity of the intravenous formulation of CT-P47 in 471 patients with rheumatoid arthritis....As a result, the main evaluation indicators showed similar levels in all three groups. The company explained that efficacy, safety, pharmacokinetics, and immunogenicity were maintained not only in the group that continued to administer CT-P47 but also in the replacement administration group that switched from the original drug to CT-P47."

P3 data • Rheumatoid Arthritis

Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis. (PubMed, Clin Drug Investig) - P3 | "Week 52 results show maintained efficacy after switching from r-TCZ to CT-P47, and comparable efficacy, pharmacokinetics, safety and immunogenicity of CT-P47 versus r-TCZ over 1 year of treatment."

Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

FDA approves expanded indication for AVTOZMA (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS) (PRNewswire) - "Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients aged 2 years and older. Following FDA approval of the additional indication for CRS, AVTOZMA IV now aligns with all indications approved for ACTEMRA IV in the United States....In accordance with the patent settlement agreement with Genentech, the IV formulation of AVTOZMA is expected to be available in the U.S. on August 31, 2025."

Biosimilar launch • Cytokine release syndrome • FDA approval • Immunology

Binex inks new Celltrion deal to make clinical-stage biosimilars (Korea Biomedical Review) - "Korea-based CDMO Binex has secured a fresh manufacturing deal with Celltrion to produce drug substances for two clinical-stage biosimilar candidates, the company said Monday. Under the contract, Binex will receive Celltrion’s process technology to manufacture the unnamed biologics at its facilities in Songdo and Osong. Financial details and product names were not disclosed due to confidentiality terms....That collaboration led to the commercial launch of Avtozma, Celltrion’s Actemra (tocilizumab) biosimilar used to treat autoimmune diseases, which Binex now produces at scale for global distribution."

Licensing / partnership • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis