Tofidence (tocilizumab-bavi) / Bio-Thera Solutions, Biogen, Organon - LARVOL DELTA

A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product. (PubMed, Rheumatol Ther) - P1, P3 | "The results of these post hoc analyses did not indicate any clinically relevant differences in the immunogenicity profile of intravenously administered BAT1806 compared with TCZ."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Organon Acquires TOFIDENCE (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA (tocilizumab) Injection, for Intravenous Infusion in the U.S. (Businesswire) - "Organon...announced that it has acquired from Biogen Inc. (Nasdaq: BIIB) regulatory and commercial rights in the U.S. for TOFIDENCE, a biosimilar to ACTEMRA, for intravenous infusion....Under the terms of the agreement, Organon has acquired the regulatory and commercial rights to TOFIDENCE in the U.S., available in three vial sizes, 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, for further dilution prior to intravenous infusion. Bio-Thera Solutions Ltd., the product developer, will maintain manufacturing rights for TOFIDENCE for the U.S. market."

Commercial • Idiopathic Arthritis • Rheumatoid Arthritis

Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab. (PubMed, BioDrugs) - "Comparative structure activity relationship characterization of BAT1806/BIIB800 and TCZ indicated that there are no relevant differences in quality attributes between BAT1806/BIIB800 and reference TCZ. Observed differences between BAT1806/BIIB800 and TCZ had no functional impact on BAT1806/BIIB800. The results support the conclusion that BAT1806/BIIB800 is similar to TCZ."

Journal • IL6R

NL-TCZ-12280: A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants (clinicaltrials.gov) - P1 | N=300 | Completed | Sponsor: Biogen | Recruiting ➔ Completed

Trial completion

Bio-Thera Solutions and Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE (BAT1806/BIIB800), an approved Biosimilar referencing tocilizumab in Arthritis Research & Therapy (PRNewswire) - "Bio-Thera Solutions, Ltd. today announced, in collaboration with Biogen, the publication in the journal Arthritis Research & Therapy of results from Treatment Period 2 (TP2; study weeks 24-48) of a Phase 3 clinical study evaluating BAT1806/BIIB800, an approved biosimilar to Actemra/RoActemra3 (tocilizumab)."

P3 data • Immunology • Rheumatoid Arthritis • Rheumatology

A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48). (PubMed, Arthritis Res Ther) - P3 | "In TP2, efficacy, safety, immunogenicity, and pharmacokinetic profiles were comparable between the TCZ, TCZ to BAT1806/BIIB800, and BAT1806/BIIB800 groups."

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

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=300 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting

Enrollment closed

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=300 | Recruiting | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Recruiting | N=150 ➔ 300 | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date

TOFIDENCE (tocilizumab), a Biosimilar Referencing ROACTEMRA, Approved in the European Union (GlobeNewswire) - "Biogen Inc...announced that the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19....The EC approval of TOFIDENCE is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package."

EMA approval • Idiopathic Arthritis • Immunology • Rheumatoid Arthritis

Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab. (PubMed, BioDrugs) - "BAT1806/BIIB800 and TCZ were highly similar for all critical quality attributes. Where differences were observed in less critical quality attributes, additional analytical assessments and clinical study results determined these to be not clinically meaningful."

Journal • IL6R

Biogen Receives Positive CHMP Opinion for TOFIDENCE (tocilizumab), a Biosimilar Referencing ROACTEMRA (GlobeNewswire) - "Biogen...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE....This positive CHMP opinion on TOFIDENCE was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package."

European regulatory • Idiopathic Arthritis • Rheumatoid Arthritis

Case demonstration of integrated biosimilars (i.e. Tofidence-Tocilizumab and Pobevcy-Bevacizumab) (EUROBIOSIMILARS 2024) - No abstract available

Clinical • Oncology

A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants (clinicaltrials.gov) - P1 | N=300 | Recruiting | Sponsor: Biogen

New P1 trial

Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial. (PubMed, Lancet Rheumatol) - P3 | "BAT1806/BIIB800 showed equivalent efficacy, and comparable safety, immunogenicity, and pharmacokinetic profiles as reference tocilizumab."

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

FDA Approves the first Actemra biosimilar- called tocilizumab-bavi (Tofidence) or BIIB800 (during development). This IV FORMULATION is approved for use in active RA, polyarticular JIA and systemic JIA. https://bit.ly/3TzVACp https://bit.ly/3tsZQsM https://bit.ly/3NzIRvy

Regulatory

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Roche and Biogen reach agreement on patent infringement lawsuit against Actemra similar [Google translation] (News The Voice Healthcare) - "Referring to Roche's Actemra, a patent infringement lawsuit related to Tofidence, the first biosimilar approved by the FDA, was dismissed following an agreement between both parties. Roche filed a patent infringement lawsuit against MabThera against Biogen and its original developer, China's BioThera, in the Massachusetts District Court last July, and as of the 23rd, the legal dispute was concluded based on an agreement between the two parties. However, general agreement details, such as coordination of the launch schedule of similar products or payment of royalties for patent rights, were not disclosed."

Corporate lawsuit • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis

FDA Approves Biogen’s TOFIDENCE (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA (Biogen Press Release) - "Biogen Inc...announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis....The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022."

BLA • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis

A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1 trial

China NMPA Approves Bio-Thera Solutions’ BAT1806, A Biosimilar to Actemra (Tocilizumab) (Businesswire) - "Bio-Thera Solutions, Ltd...announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of Actemra® (tocilizumab), in China. BAT1806 is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world and has been approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS)..."

Non-US regulatory • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

"China NMPA Approves Bio-Thera Solutions’ BAT1806, A Biosimilar to Actemra® (Tocilizumab) https://t.co/mwfOxBFKEW" (@NewsFromBW)

FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA (tocilizumab) (GlobeNewswire) - "Biogen Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. ACTEMRA® is indicated for several indications, including moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis. 'The FDA filing is supported by Phase 3 data from a comparative clinical trial demonstrating equivalent efficacy and a comparable safety and immunogenicity profile to the reference product...'"

BLA • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Fifty-two-week Results from a Phase 3, Randomized, Double-blind, Active-controlled Clinical Trial to Compare BAT1806/BIIB800, a Proposed Tocilizumab Biosimilar, with a Tocilizumab Reference Product in Subjects with Moderate to Severe RA with an Inadequate Response to Methotrexate (ACR Convergence 2022) - "Efficacy, safety, immunogenicity, and PK profiles were comparable between BAT1806, TCZ/BAT1806, and TCZ throughout TP2. No safety or clinically relevant immunogenicity issues were observed in subjects switched from TCZ to BAT1806"

Clinical • P3 data • Infectious Disease • Novel Coronavirus Disease • Otorhinolaryngology • Pneumonia • Respiratory Diseases

Biogen Announced EMA Filing Acceptance of BIIB800, A Biosimilar Candidate Referencing RoACTEMRA (tocilizumab) (GlobeNewswire) - "Biogen Inc...announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BIIB800, a biosimilar candidate referencing RoACTEMRA® (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody....The MAA includes positive Phase 32 data for BIIB800 from the clinical program of a multicenter, multinational, randomized, double-blind, parallel-group, active-control study, designed to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of BIIB800 compared to RoACTEMRA® in 621 patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate."

European regulatory • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Biogen and Bio-Thera Solutions Present Positive Phase 3 Data for Tocilizumab Biosimilar Candidate at the Annual European Congress of Rheumatology (EULAR 2022) (GlobeNewswire) - P3 | N=621 | NCT03830203 | Sponsor: Bio-Thera Solutions | "Biogen Inc...and Bio-Thera Solutions, Ltd...presented positive Phase 3 data for BIIB800 (BAT1806)...at the Annual European Congress of Rheumatology (EULAR 2022). Data from the Phase 3 comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product....The primary endpoints were ACR20* response at week 12 and week 24. The ACR20 response rates in the BIIB800 group and the reference tocilizumab group were 68.97% vs. 64.82% at week 12 and 69.89% vs. 67.94% at week 24. The estimated difference between the two groups were within the pre-defined equivalence margins (4.15% (95% CI - 3.63 to 11.93) at week 12 and 1.94% (90% CI -4.04 to 7.92; 95% CI -5.18 to 9.07) at week 24."

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