BCD-055 (infliximab biosimilar) / Biocad - LARVOL DELTA

Dose Escalation With Infliximab Biosimilar Can Restore Responses in IBD (MedPageToday) - "In dose-escalated patients, clinical response was 49.4% in those with ulcerative colitis and 61.5% in those with Crohn's disease, while clinical remission rates were 24.7% and 53.8%, respectively, reported Silvio Danese, MD, PhD...at the Crohn's & Colitis Congress."

Biosimilars for Chronic Inflammation Management - Episode 2: Difference Between Biosimilars and Reference Product (Rheumatology Network) - "Joel M. Gelfand, MD, MSCE, FAAD: They are just that. The reference product is usually the originator biologic, the one that did large-scale pivotal trials, often placebo-controlled or active comparator studies, competitor studies, or some type of standard of care. We've been using a lot of these molecules for decades. For example, etanercept and infliximab were approved in the late 1990s. Then the biosimilar product is a manufactured biologic process that, as you mentioned, doesn't differ chemically or structurally in any important ways from the originator product, and then clinically has demonstrated very similar safety and efficacy."

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Comparative efficacy and safety of infliximab and its biosimilars in patients with rheumatoid arthritis presenting an insufficient response to methotrexate : A network meta-analysis. (PubMed, Z Rheumatol) - "No significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations."

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

[VIRTUAL] Biologics to Treat Adults with Active Radiographic Axial Spondyloarthritis in the Russian Federation- Number Needed to Treat and Cost per Responder (ISPOR 2021) - "METHODS The study is based on the results of a systematic review and network meta-analysis comparing the effectiveness of biologics: netakimab, ixekizumab, secukinumab, adalimumab, infliximab, etanercept, golimumab and certolizumab pegol, in adults with active r-AxSpA in Russia. CONCLUSIONS This study complements the systematic review and network meta-analysis of relative effectiveness of biologics in adults with active r-AxSpA in Russia. The results may be a useful tool for treatment decision-making."

Clinical • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

[VIRTUAL] Number Needed to Treat and Incremental Costs per Responder for Biologics in Adult Patients with Active Radiographic Axial Spondyloarthritis in the Russian Federation (ISPOR 2021) - "Risk differences were obtained from the results of a systematic review and network meta-analysis evaluating effectiveness of biologics to treat r-AxSpA in Russia: netakimab, ixekizumab, adalimumab, infliximab, etanercept, and certolizumab pegol. The highest CpR was attributed to etanercept 25 mg. CONCLUSIONS The analyses resulted in netakimab being the most cost-effective treatment option, while etanercept 25 mg was the least cost-effective among biologics to treat active r-AxSpA in Russia."

Clinical • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

[VIRTUAL] Comparative Efficacy of Synthetic and Biologic Dmards for Adult Patients with ACTIVE Psoriatic Arthritis in the Russian Federation- A Systematic Review and Network Meta-Analysis (ISPOR-EU 2020) - " Phase II and III randomised controlled trials (RCTs) evaluating efficacy of sDMARDS (tofacitinib, apremilast) and bDMARDS (netakimab, guselkumab, ustekinumab, secukinumab, ixekizumab, adalimumab, etanercept, infliximab, certolizumab, golimumab) for active PsA were identified by systematic literature review performed in Pubmed and Embase databases. Netakimab is one of the most effective treatments for active PsA."

Retrospective data • Review • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

[VIRTUAL] EFFICACY AND SAFETY OF BIOLOGICS FOR THE TREATMENT OF ADULT PATIENTS WITH RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS IN RUSSIA- SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS. (ISPOR 2020) - "OBJECTIVES: To compare the efficacy and safety of biologics, approved and reimbursed in Russia (netakimab, secukinumab, ustekinumab, infliximab, adalimumab, etanercept, golimumab, certolizumab pegol) in adults with r-axSpA. Results suggest that except for ASAS 20, ASAS 40 and ASAS 5/6 outcomes, all biologics have comparable efficacy and similar safety profile."

Retrospective data • Review • Ankylosing Spondylitis • Immunology • Spondylarthritis

BCD-055: Launch in Russia for ankylosing spondylitis by end of 2018 (Biocad) - Clinical Trial Update

Launch non-US • Biosimilar

Russia approves its local company BIOCAD’s infliximab biosimilar for ankylosing spondylitis (Ankylosing Spondylitis News) - “Russian regulators have approved the Russian company BIOCAD’s infliximab biosimilar as a treatment for rheumatoid arthritis and ankylosing spondylitis….The approval was based on extensive preclinical-trial studies and trial results showing that BIOCAD is similar to Janssen’s Remicade…”

Non-US regulatory • Ankylosing Spondylitis • Biosimilar • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis

A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study. (PubMed, Rheumatol Int) - P3 | "Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm (p = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study.Trial registration ClinicalTrials.gov ID, number NCT02762838."

Clinical • Journal • P3 data

SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS COMPARING NETAKIMAB WITH OTHER BIOLOGIC AGENTS USED TO TREAT ADULT PATIENTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS IN RUSSIA (ISPOR-EU 2019) - "OBJECTIVES: To compare the efficacy and safety of a new biologic netakimab and biologic agents approved and reimbursed in Russia (secukinumab, ustekinumab, infliximab, adalimumab, etanercept) in adults with moderate-to-severe plaque psoriasis. Obtained results suggest that netakimab has efficacy superior to or comparable with other biologics and a similar safety profile."

Retrospective data • Review

The Experience With Biosimilars Of Infliximab In Rheumatic Diseases. (PubMed, Curr Pharm Des) - "Clinical data published so far have provided important evidence on long-term efficacy and safety, immunogenicity and switching, supporting the use of CT-P13 and SB2 for the treatment of rheumatic diseases. In addition, the European experience has proved the economic advantages of the incorporation of infliximab biosimilars in clinical practice. Despite the widespread use of infliximab biosimilars there is still a lack of data regarding interchangeability between reference products and biosimilars."

Journal

Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis (clinicaltrials.gov) - P3; N=426; Completed; Sponsor: Biocad; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion