Erelzi (etanercept-szzs) / Sandoz - LARVOL DELTA

[Corrected] Sandoz files antitrust litigation against Amgen regarding patient access to etanercept biosimilar in the US (GlobeNewswire) - "Sandoz...announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998...Etanercept is a biologic medicine used to treat a range of disabling inflammatory diseases. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi+ (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. In 2024, Enbrel generated USD 3.3 billion in revenue in the US....Sandoz is seeking an injunction to prevent Amgen from using certain patent rights to block biosimilar competition and allow Sandoz to launch Erelzi as soon as possible. The company is also seeking damages, which could be tripled under applicable laws."

Patent • Ankylosing Spondylitis • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis

Sandoz files antitrust litigation against Amgen regarding patient access to etanercept biosimilar in the US (GlobeNewswire) - "Sandoz...announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998....Sandoz is seeking an injunction to prevent Amgen from using certain patent rights to block biosimilar competition and allow Sandoz to launch Erelzi as soon as possible. The company is also seeking damages, which could be tripled under applicable laws. The lawsuit was filed in the US District Court for the Eastern District of Virginia."

Corporate lawsuit • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis

Similar Etanercept Adherence in Individuals with Rheumatic Disease Initiating Originator and Biosimilar: A Population-Based Study (ACR Convergence 2024) - "ETA-O (Enbrel) and ETA-B (Brenzys, Erelzi) were defined using Drug Identification Numbers...We adjusted for sex at birth, age at ETA initiation, and biologic use and prednisone use prior to ETA initiation. Among 615 ETA initiators, 50.8% initiated ETA-B... In this Canadian population-based study of ETA initiators with rheumatic disease, ETA-B and ETA-O had similar adherence. Low adherence is common among these individuals but is better in older individuals. A potential limitation was our assumption that every individual was under the same maintenance regimen (50 mg sc weekly)."

Adherence • Clinical • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Real-World Evidence for GP2015 in Patients with Rheumatoid Arthritis: Safety Outcomes from German Observational Data (ACR Convergence 2024) - "Patient characteristics were generally balanced with the profile of patients with RA from a previous study,3 and no new safety signals were identified. Overall, the real-world incidence of SAEs in patients treated with GP2015 was low and comparable with the safety profile of reference etanercept.4"

Clinical • HEOR • Observational data • Real-world • Real-world evidence • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Immunology • Infectious Disease • Inflammatory Arthritis • Myocardial Infarction • Pain • Rheumatoid Arthritis • Rheumatology

SAFETY OF BIOSIMILAR ETANERCEPT GP2015 IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS FROM A UK-BASED REGISTRY STUDY (EULAR 2024) - "GP2015 was associated with a significantly lower aHR for time to first serious infection versus other anti-TNFs and a lower, but nonsignificant, aHR versus csDMARDs. Due to the sample size, further investigations are required to confirm if GP2015 can be considered in patients in whom infection risk is a concern."

Clinical • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Charting the Etanercept Journey: Tracing Cost Dynamics in Poland's Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly. (PubMed, BioDrugs) - "This nation-level scenario of market re-monopolization by a biosimilar drug confirms net loss and excess costs for the healthcare payer, as can be expected from economic theory. The upwards drug repricing and restriction of treatment availability occurs much more rapidly than the decrement in a period of market competition."

Journal

Effectiveness and safety of biosimilar etanercept GP2015 in patients with rheumatoid arthritis in the UK: results from the COMPACT study (BSR 2024) - "Over 24 weeks of treatment with GP2015, disease activity remained low and stable in patients with RA previously switched from reference ETN or from another biosimilar ETN, with no new safety concerns observed. These results from a cohort of patients with RA treated in the UK are consistent with effectiveness, QoL and safety data reported previously for the total population in the COMPACT study."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Similar Treatment Adherence Between Individuals with Rheumatic Diseases Treated with Etanercept Originator and Biosimilar: a Population-Based Study (CRA-AHPA 2024) - "ETA-O (Enbrel) and ETA-B (Brenzys, Erelzi) were defined using Drug Identification Numbers...We assessed adherence during the first year for bio-originator versus biosimilar initiators using logistic regression models, adjusted for sex at birth, age at ETA initiation, calendar year, and biologic use and prednisone use prior to ETA initiation... For rheumatic disease patients initiating ETA, both originator and biosimilar had similar adherence. Low adherence is common among these patients but better in older individuals. Limitations of our analyses include our assumption that every individual was under same regimens and that reasons for nonadherence/treatment gaps are not available in claims data."

Adherence • Clinical • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Forty-Eight-Month Monitoring of Disease Activity in Patients with Long-Standing Rheumatoid Arthritis Treated with TNF-α Inhibitors: Time for Clinical Outcome Prediction and Biosimilar vs Biologic Originator Performance. (PubMed, Clin Drug Investig) - "We conclude that biosimilars of adalimumab and etanercept have equivalent effectiveness over a long period of time compared to their originator drugs, and also that the levels of disease activity after 6 months of tumor necrosis factor-α inhibitors (originator drugs and biosimilars) might predict the response to therapy at 4 years in patients with long-standing rheumatoid arthritis."

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

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch. (PubMed, Drug Saf) - "This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity."

Biosimilar launch • Journal • Real-world • Real-world evidence

Outcomes in Patients with Rheumatoid Arthritis Initiating Therapy with Etanercept, Adalimumab, or Janus Kinase Inhibitors (ACR Convergence 2023) - "Background/Purpose: Ongoing debate exists regarding the optimal sequence of tumor necrosis factor inhibitors and Janus kinase inhibitors (JAKis) in patients with rheumatoid arthritis (RA) as first-line biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) therapy following conventional therapies.The aim of this study was to describe baseline characteristics, effectiveness, persistency, and treatment patterns among first-line b/tsDMARD-naive initiators of etanercept (ETN), adalimumab (ADA), or JAKis (tofacitinib, baricitinib, and upadacitinib)... In this real-world study in patients initiating first-line b/tsDMARD therapy with ETN, ADA, or JAKis, we did not observe differences in clinical effectiveness/patient-reported outcomes and treatment persistency at 6M and 12M after treatment initiation. Patient Description at Time of Initiation and Unadjusted Disease Activity Results Adjusted Mean Differences in Change in Effectiveness and..."

Clinical • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • Thermal Injury

Real-World Drug Persistence of GP2015, an Etanercept Biosimilar, in Patients with Rheumatoid Arthritis: Results from the Multi-Country COMPACT Study (ACR Convergence 2023) - "The results of the study show high treatment persistence under GP2015 treatment in RA patients under real-world conditions. The results are in line with the reported persistence rates in the overall study population. Patients who were on previous iETN treatment and who had stable disease presented the highest drug survival rates after switch to GP2015."

Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Influence of Rheumatoid Factor on Serum Drug Levels of TNF Inhibitors with Different Structures in Rheumatoid Arthritis (ACR Convergence 2023) - "A significantly lower efficacy of TNF inhibitors (TNFi) monoclonal antibodies (mAbs), Infliximab (IFX) and Adalimumab (ADL) as well as the fusion protein etanercept, in seropositive RA patients with high RF levels has been described 1,2... Baseline RF titers do not impact serum drug levels of CZP (a Fc-free anti-TNF ) whereas they are significantly linked to low serum drug levels of complete monoclonal antibodies (IFX and ADL) in clinical settings in RA patients. These differences might aid physicians to select suitable treatment for the management of RA. Demographics characteristics of patients with RA treated with infliximab (IFX), adalimumab (ADL) and certolizumab (CTZ) at baseline."

Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Infusion of Etanercept into the Peripheral Lymphatics Significantly Reduces Disease Activity in Rheumatoid Arthritis Patients with Inadequate Response to Subcutaneous Injections (ACR Convergence 2023) - "The NTM device effectively infused etanercept into the peripheral lymphatics that drain to the LN. The NTM device was well accepted by all patients with an application pain rating of 3.8 ± 3.6 mm on a 100 mm VAS scale. DAS28(CRP) scores, 28TJC and 28SJC, and Global Disease Activity and Pain were improved in all patients infused with the NTM device at half the SC injection dose administered weekly, biweekly, and monthly."

Clinical • Dermatology • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology

Effectiveness of GP2015 in biologic-naïve patients with early rheumatoid arthritis: Results from the COMPACT Study (SCR 2023) - "The results show comparable disease activity scores through 12 months in patients with early RA who were biologic-naïve and started GP2015 after conventional therapy failure. These results are consistent with previously reported effectiveness and PRO data from COMPACT study (2,3)."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. (PubMed, Am J Clin Dermatol) - P3 | "Secukinumab was well tolerated in pediatric patients with moderate to severe and severe plaque psoriasis across age and bodyweight subgroups. The overall safety profile of secukinumab in pediatric patients was consistent with that of adult patients."

Clinical • Journal • P3 data • Dermatology • Hematological Disorders • Immunology • Infectious Disease • Neutropenia • Pediatrics • Psoriasis

EIGHT-MONTH FOLLOW-UP OF THE NON-MEDICAL SWITCH FROM ETANERCEPT BIO-ORIGINATOR TO GP-2015 OR SB4 ETANERCEPT BIOSIMILARS IN PATIENTS WITH CHRONIC INFLAMMATORY ARTHROPATHIES: A MONOCENTRIC OBSERVATIONAL STUDY (EULAR 2023) - "Conclusion Our data indicate that the switch to GP-2015 or SB4 ETA biosimilars from ETA bio-originator does not bear clinical and laboratory differences in patients with chronic arthropathies. The worse outcome in PROs, which we also observed in the adalimumab bio-originator to biosimilar switch (3), does not reflect a worsening of disease activity indexes and could indicate a possible nocebo response."

Clinical • Observational data • Ankylosing Spondylitis • Breast Cancer • Genetic Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Pain • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Skin Cancer • Solid Tumor

OUTCOMES OF THE SELF-INJECTION ASSESSMENT QUESTIONNAIRE IN RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS AND PSORIATIC ARTHRITIS PATIENTS RECEIVING GP2015 (ETANERCEPT BIOSIMILAR) IN A REAL-WORLD STUDY: FINAL RESULTS FROM COMPACT STUDY (EULAR 2023) - "Conclusion The SIAQ showed high acceptance of the auto-injector device in both countries where the survey was performed across all indications. Most RA pts were satisfied with auto-injector device usability after switching from iETN to GP2015, demonstrating no major concerns after switching."

Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Patient-reported Outcomes and Quality of Life in Patients with Rheumatoid Arthritis Treated with GP2015: Final Results from a Real-world Study (ACR Convergence 2022) - "This final analysis showed comparable PRO and QoL scores obtained after 12 months of observation in patients with RA who switched from iETN to GP2015 and patients who were biologic-naïve and started GP2015 after conventional therapy failure."

Clinical • HEOR • Patient reported outcomes • Real-world evidence • Ankylosing Spondylitis • Fatigue • Immunology • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Real-world effectiveness and persistence of reference etanercept versus biosimilar etanercept GP2015 among rheumatoid arthritis patients: A cohort study. (PubMed, Front Pharmacol) - "Drug survival was 82% and 80% for ETN and GP2015, respectively (log-rank p-value = 0.804). Etanercept and its biosimilar GP2015 show similar effectiveness and treatment persistence in RA patients in a real-life setting."

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

Safety and patient-reported outcomes in patients with psoriatic arthritis who were treated with Etanercept biosimilar GP2015: Final results of the COMPACT study (EADV 2022) - No abstract available

Clinical • Patient reported outcomes • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Effectiveness and safety of a biosimilar-to-biosimilar switch of the TNF inhibitor etanercept in patients with chronic inflammatory rheumatic diseases. (PubMed, Ther Adv Musculoskelet Dis) - "We aim to study the effectiveness and safety of a non-medical bsDMARD-to-bsDMARD switch from originator etanercept (ETN) to bsDMARD ETN (SB4) and successive to another bsDMARD ETN (GP2015) in patients with chronic inflammatory rheumatic diseases in a real-life setting. The retention rate after switches from originator ETN to two ETN bsDMARD was close to 90%. Multiple switches resulted in a high adherence rate without clinically important efficacy or safety signals."

Journal • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Real-world Effectiveness and Safety of GP2015 in Patients with Rheumatic Diseases: Final results of the COMPACT Study (EULAR 2022) - "The results show comparable disease activity scores between pts who were switched from iETN, pts switched from other targeted therapies and biologic-naïve pts after 12 months of treatment with GP2015. No impact on the effectiveness of ETN was observed in pts with RA, axSpA or PsA who switched to GP2015. No new safety signals were reported."

Clinical • Real-world evidence • Ankylosing Spondylitis • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Expanded Table: Some biologic drugs and JAK inhibitors for rheumatoid arthritis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Treatment patterns and health care costs among patients with psoriatic arthritis treated with biologic or targeted synthetic disease-modifying antirheumatic drugs. (PubMed, J Manag Care Spec Pharm) - "Adult PsA patients with at least 1 claim for an approved PsA biologic (adalimumab, certolizumab, etanercept, golimumab, infliximab, secukinumab, or ustekinumab) or tsDMARD (apremilast or tofacitinib) between January 1, 2015, and June 30, 2019, were selected from the IBM MarketScan administrative claims databases...Ogdie has received consulting fees from Amgen, AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Lilly, Novartis, and Pfizer and has also received grant support from Pfizer, Novartis, and Amgen. Portions of these data have been presented in poster form at the virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2020 and Congress of Clinical Rheumatology (CCR) West 2020 conferences."

HEOR • Journal • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies