TNFcept (etanercept biosimilar) / LG Chem, Mochida, AYUMI Pharma - LARVOL DELTA

Clinical and Real-World Evidence on Etanercept Biosimilar Switching: A Narrative Literature Review of Efficacy and Safety. (PubMed, Adv Ther) - "This review examines clinical and real-world data on the effects of switching between reference and biosimilar (SDZ-ETN, SB4, LBEC0101, YLB113) etanercept on treatment efficacy and safety in patients with inflammatory rheumatic and musculoskeletal diseases. These findings support broader biosimilar adoption to improve patient access and reduce healthcare costs. However, published data on multiple biosimilar switches and patient-reported outcomes remain limited, warranting further research efforts in these areas."

Clinical • HEOR • Journal • Real-world evidence • Review • Ankylosing Spondylitis • Dermatology • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

SAFETY AND EFFECTIVENESS OF ETANERCEPT BIOSIMILAR LBEC0101 FOR RHEUMATIC DISEASES IN SOUTH KOREA: REAL-WORLD POST-MARKETING SURVEILLANCE DATA (EULAR 2024) - "This post-marketing surveillance study successfully provided long-term (up to 52 weeks) real-world data on the efficacy and safety of LBEC0101 for treating rheumatoid arthritis and ankylosing spondylitis. While the study observed a higher incidence of adverse events and reactions compared to other studies, these were generally less severe. Factors such as concurrent medications and conditions, including possible links to the COVID-19 vaccine, were considered in the analysis."

Clinical • P4 data • Real-world • Real-world evidence • Ankylosing Spondylitis • Dermatology • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Pain • Novel Coronavirus Disease • Pruritus • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Comparison of safety and effectiveness between etanercept biosimilar LBEC0101 and reference in patients with rheumatoid arthritis in real-world data using the KURAMA cohort. (PubMed, Mod Rheumatol) - "This real-world cohort study confirmed that the biosimilar of ETN, LBEC0101, was comparable to the reference product in terms of continuation rate, effectiveness at initiation of introduction, and effect persistence before and after switching in clinical practice."

Journal • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Xenotransplantation of a novel immune-isolation device encapsulating porcine islets improved blood glucose levels in diabetic common marmosets without immunosuppressive drugs. (IPITA-IXA-CTRMS 2023) - "Anti-inflammatory drugs, etanercept, tofacitinib were administered to some of them, but no immunosuppressive drugs were used (n=7)... These results demonstrate the potential of the porcine islet-encapsulating device in the treatment of diabetes in preclinical studies."

Preclinical • Diabetes • Fibrosis • Immunology • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

EFFECTS OF SWITCHING FROM ETANERCEPT ORIGINATOR TO ETANERCEPT BIOSIMILAR ON DISEASE ACTIVITY, PHYSICAL FUNCTION, AND PATIENT-REPORTED OUTCOME REGARDING A SELF-INJECTION DEVICE IN PATIENTS WITH WELL-CONTROLLED RHEUMATOID ARTHRITIS (EULAR 2022) - "Objectives: This retrospective study investigated the effects of switching from etanercept originator (ETN-OR) to ETN biosimilar (ETN-BS: LBEC0101 developed by LG Chem) on disease activity, physical function, and patient reported outcome (PRO) regarding a self-injection device in patients with well-controlled RA... Switching from ETN-OR to ETN-BS worsened disease activity in well-controlled RA patients in our real-world clinical practice due to not objective findings, but subjective complaints by RA patient. We thought that nocebo effect was one of the reasons to explain the results. On the other hand, the PRO regarding the injection device was improved."

Clinical • Patient reported outcomes • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology

REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST) (clinicaltrials.gov) - P4; N=448; Not yet recruiting; Sponsor: Hanyang University Seoul Hospital

Clinical • New P4 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

Comparative efficacy and safety of etanercept biosimilars in comparison with etanercept in patients with rheumatoid arthritis who have insufficient response to methotrexate: A network meta-analysis. (PubMed, Int J Clin Pharmacol Ther) - "No significant difference was found between etanercept biosimilars and etanercept originators in patients with active RA despite treatment with MTX in terms of the ACR20 response rate and SAEs."

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

Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study. (PubMed, Arthritis Res Ther) - P3 | "Administration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101."

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

A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy (clinicaltrials.gov) - P3; N=372; Active, not recruiting; Sponsor: LG Life Sciences; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

LG chem to unveil its first biosimilar in Japan next year (The Korea Herald) - "LG Chem is expected to commercialize its first copycat version of a pricey biologic drug early 2018 in Korea and Japan...The company has applied to Japan’s Health Ministry for approval of its biosimilar candidate LBEC0101 referencing Amgen’s blockbuster rheumatoid arthritis drug Enbrel. It expects to clear the final regulatory hurdle by the end of this year...'Starting with the Enbrel biosimilar in 2018, we hope to gain global competitiveness in the biosimilar markets of Japan and Korea...'"

Biosimilar launch • Japanese regulatory • Non-US regulatory • Biosimilar • Immunology • Inflammation • Psoriasis • Rheumatoid Arthritis

LG Chem launches Enbrel biosimilar in Japan (The Investor) - "LG Chem said on May 30 that it has launched Etanercept BS [MA], its biosimilar referencing Amgen’s rheumatoid arthritis drug Enbrel in Japan."

Launch Japan • Biosimilar

LG Chem obtains approval for sale of biosimilar etanercept in Japan (Yonhap News Agency) - "LG Chem Ltd....has obtained Japanese approval to sell its biosimilar etanercept for the treatment of rheumatoid arthritis."

Japanese regulatory • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

LBEC0101, an etanercept biosimilar for the treatment of rheumatoid arthritis. (PubMed, Expert Opin Biol Ther) - "An extension study showed that efficacy was sustained long-term in patients receiving LBEC0101 and in those switching from the ETN-RP to LBEC0101. The safety profile of LBEC0101 was also confirmed to be comparable with the ETN-RP.Expert Opinion: LBEC0101 has shown equivalent pharmacokinetics and efficacy and comparable safety to the ETN-RP, and the lower cost of LBEC0101 provides a good cost-benefit ratio."

Journal