Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon - LARVOL DELTA

Real-World Outcomes for HER2-Positive MBC: Exploring Global Perspectives and Regional Differences in Treatment Approaches (GBCC 2025) - "Real-World Data on Recently Approved Agents and HER2-Targeting Biosimilars Recent clinical trials have introduced several promising treatment options for HER2-positive MBC, including T-DXd, tucatinib, and T-DM1. Beyond their clinical trial efficacy, real-world studies support their effectiveness and tolerability in broader patient populations. Additionally, HER2-targeting biosimilars (e.g., Ontruzant, Herzuma) have gained widespread acceptance globally, and real-world evidence supports their comparable efficacy and safety in managing HER2-positive breast cancer."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2

ESPERO: Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Seoul National University Hospital | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Feb 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Comparative Study of MiroCam MC2000 and PillCam SB3 in Detecting Small Bowel Bleeding: A Multicenter Prospective Randomized Crossover Study. (PubMed, Gut Liver) - "The MC2000's dual-camera system appears to enhance the detection of small bowel lesions over the SB3, especially for more important lesions. These findings suggest that the MC2000 may offer superior diagnostic capabilities for patients with suspected small bowel bleeding, potentially leading to better clinical outcomes (this trial registered KCT0005591)."

Journal • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder

Variation in Provider Reimbursement for Biosimilars and Reference Biologics by Commercial Health Plans (ISPOR 2025) - "Using price data published by payers, we explored the variation in reimbursement across large payers for two biologic drugs and their biosimilars in two large metropolitan areas. We used price data from Q1 2024 for three largest payers in San Francisco and Chicago areas, each for Herceptin (trastuzumab) and its biosimilars (Ontruzant, Herzuma, Ogivri, Trazimera, and Kanjinti). Drivers of reimbursement rates include terms of confidential contracts between manufacturers, payers, and providers, and incentives for providers to use less expensive biosimilars. Payer price transparency data offer a unique opportunity to understand how reimbursement incentivizes providers. It may be used to explore the impact of biosimilar competition on spending on trastuzumab products across commercial markets."

HEOR • Reimbursement • US reimbursement

Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2024 (GlobeNewswire) - "Biosimilars revenue increased 12% on both an as-reported and ex-FX basis for full year 2024, compared with the prior year, primarily driven by growth in Hadlima, following its U.S. launch in July 2023. Renflexis and Ontruzant declined 1% ex-FX and 9% ex-FX, respectively, as both products are in the mature phase of their product life cycles and face significant competitive pricing pressure. Established Brands revenue grew 2% both on an as-reported basis and ex-FX in the fourth quarter of 2024, primarily related to the revenue contribution of Emgality (galcanezumab-gnlm) and Vtama (tapinarof), which together more than offset the impact of the loss of exclusivity ('LOE') of Atozet (ezetimibe and atorvastatin) in key markets in Europe and in Japan."

Commercial • Ankylosing Spondylitis • Atherosclerosis • Atopic Dermatitis • Breast Cancer • Crohn's disease • Dyslipidemia • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Migraine • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Pertuzumab and Trastuzumab Biosimilars in Real-Life Association for the First-Line Treatment of HER2-Positive Metastatic Breast Cancer: the prospective, observational PETRA study (SABCS 2024) - "TBs used were Trazimera® in 39 patients (34.8%), Ontruzant® in 27 (24.1%), Herzuma® in 23 (20.5%), Ogivri® in 19 (17.0%), and Kanjinti® in 4 (3.6%). The majority of chemotherapy regimens were paclitaxel in 90 patients (80.4%), followed by docetaxel in 18 (16.1%) and vinorelbine in 4 (3.6%)... Trastuzumab biosimilars appear to be similar to Herceptin when combined with pertuzumab and chemotherapy in the first-line treatment of metastatic HER2-positive breast cancer. However, 13% of patients experienced a decrease in LVEF during follow-up, which is significant. Systematic and regular monitoring of cardiac toxicity is mandatory."

Clinical • Metastases • Observational data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Contemporary patterns of Medicare Utilization and Spending on Herceptin and its Biosimilars in Breast Cancer. (SABCS 2024) - "The six FDA approved Herceptin biosimilars are: Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, and Hercessi. There has been a significant decline in Herceptin utilization and spending, accompanied by a shift towards biosimilars; reflecting changing trends in HER2-positive breast cancer treatments. Kanjinti and Trazimera, in particular, experienced substantial increases in spending, dosage units, claims, and beneficiaries, indicating growing acceptance and usage. Despite these increases, total spending and claims for Herceptin remain higher than for its biosimilars."

Medicare • Reimbursement • US reimbursement • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Real-World Safety and Effectiveness of Switching among Biosimilars in HER2-Positive Breast Cancer (SABCS 2024) - "Results A total of 48 patients with HER2-positive breast cancer were enrolled from two centers (Center 1: 25 patients, Center 2: 23 patients) and all received 3-weekly trastuzumab therapy and 27 patients (56%) also received pertuzumab...The overall response rate (ORR) among assessable MBC patients was 35% (patients at different lines of therapy) Conclusion This study demonstrates that switching from another trastuzumab biosimilar to Ogivri in HER2-positive breast cancer patients is safe, with no infusion-related reactions or cardiac events reported post-switch, without jeopardizing treatment effectiveness. This research addresses a critical gap in real-world data on switching among biosimilars, providing essential insights for healthcare decision-making"

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Trastuzumab biosimilars interchangeability: Preliminary real-world data in neoadjuvant breast cancer setting. (ASCO 2024) - " Along the studied period, SUS had offered 3 T biosimilars: ABP 980 (Amgen), CT-P6 (Celltrion), SB3 (Samsung), plus reference trastuzumab (Roche). The standard regimen was ACq21 4cycles followed by Taxane (Docetaxel q21 or weekly Paclitaxel) plus T 4cycles... Although IC among biosimilars compound had been globally accepted, it was not clinically fully tested. Brazilian Ministry of Health, as the only provider, has a policy based on lowest cost for trastuzumab compound, causing constant changes along pts treatments. Furthermore, it is expected that Brazil has the potential to evaluate the IC in thousands of pts prospectively next years."

Clinical • Real-world • Real-world evidence • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Trastuzumab biosimilar (TB) in combination with pertuzumab (P) and chemotherapy (ct) in HER2 positive, metastatic breast cancer (mBC): Efficacy and safety (ESMO-BC 2024) - "TB was TRAZIMERA® in 38 pts (34.5 %), ONTRUZANT® in 26 (23.6 %), HERZUMA® in 23 (20.9 %), OGIVRI® in 19 (17.3%) and KANJINTI® in 4 (3.6 %). Chemotherapy was weekly paclitaxel in 80.0 % of pts, docetaxel in 16.4 %, vinorelbine in 3.6 %...Two pts experienced grade 3 and 4 CHF, respectively. Conclusions Efficacy and tolerance of TB appears comparable to HERCEPTIN in the metastatic setting, as reported in previous clinical trials."

Clinical • Combination therapy • Metastases • Breast Cancer • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Interstitial Lung Disease • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Asan Medical Center | Trial completion date: Mar 2023 ➔ Dec 2024 | Trial primary completion date: Mar 2023 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Biosimilar in Breast Cancer: A Narrative Review. (PubMed, Cureus) - "Trastuzumab biosimilars, such as CT-P6, Ontruzant®, ABP 980, and PF-05280014, have shown efficacy in treating HER2-positive metastatic BCs, presenting a viable alternative to the reference product. Monoclonal biosimilars present a promising avenue in BC therapy, demonstrating efficacy, safety, and potential cost savings. The integration of biosimilars into cancer treatment strategies offers a means to improve accessibility to effective care while addressing economic considerations in healthcare."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis. (PubMed, Immunopharmacol Immunotoxicol) - "The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3...Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients."

Journal • Retrospective data • Review • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

First-Line Treatment of HER2-Positive Metastatic Breast Cancer With Dual Blockade Including Biosimilar Trastuzumab (SB3): Population-Based Real-World Data From the DBCG. (PubMed, Breast Cancer (Auckl)) - "Median time on treatment was 8.7 months (95% CI, 7.6-11.4); 36 patients (31%) were still on treatment at end of study. This retrospective real-world, nationwide study demonstrated comparable median PFS to the historical data of using reference trastuzumab and pertuzumab as first-line dual blockade."

Journal • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Safety and Clinical Evaluation of Dual Inhibition with Pertuzumab and Trastuzumab Biosimilar SB3 in HER2-Positive Breast Cancer Patients. (PubMed, Breast Care (Basel)) - "The safety and the efficacy in this setting was comparable to the trastuzumab plus pertuzumab combination in neoadjuvantly treated matched samples. In this series of HER2-positive breast cancer patients, the combination of SB3 plus pertuzumab was consistent with the known safety and efficacy profile of trastuzumab and pertuzumab combination."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial. (PubMed, JAMA Netw Open) - P=N/A | "In the original trial, patients were randomized to either SB3 or TRZ with concomitant neoadjuvant chemotherapy for 8 cycles (4 cycles of docetaxel followed by 4 cycles of fluorouracil, epirubicin, and cyclophosphamide)...In this secondary analysis of a randomized clinical trial, SB3 demonstrated cardiac safety and survival comparable to those of TRZ after up to 6 years of follow-up in patients with ERBB2-positive early or locally advanced breast cancer. ClinicalTrials.gov Identifier: NCT02771795."

Clinical • Journal • Breast Cancer • Cardiovascular • Congestive Heart Failure • Heart Failure • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Safety and efficacy of trastuzumab biosimilar plus irinotecan or gemcitabine in patients with previously treated HER2 (ERBB2)-positive non-breast/non-gastric solid tumors: a phase II basket trial with circulating tumor DNA analysis. (PubMed, ESMO Open) - "Trastuzumab plus irinotecan or gemcitabine was safe and feasible for patients with previously treated HER2-positive advanced solid tumors with modest efficacy outcomes, and ctDNA analysis was useful for detecting HER2 amplification."

Circulating tumor DNA • Journal • P2 data • Pan tumor • Biliary Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study. (PubMed, Oncology) - "Safety and efficacy of SB3 demonstrated in this real-world study were comparable with previous studies of reference trastuzumab."

Journal • P4 data • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A PROSPECTIVE RANDOMIZED MULTI-CENTER COMPARISON STUDY BETWEEN DUAL-CAMERA MIROCAM MC2000 AND SINGLE- CAMERA PILLCAM SB3 IN PATIENTS WITH SUSPECTED SMALL BOWEL BLEEDING (DDW 2023) - "This study shows that MC2000 with dual camera appears to increase the detection rate of SB lesions compared with the PC3 in the diagnosis of patient with suspected SB bleeding."

Clinical

Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON) (clinicaltrials.gov) - P4 | N=108 | Recruiting | Sponsor: Institut fuer Frauengesundheit | Trial completion date: Jan 2023 ➔ Jul 2023 | Trial primary completion date: Jan 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

One-year safety, immunogenicity, and survival results from a phase III study comparing SB3 (a proposed trastuzumab biosimilar) and originator trastuzumab in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment (ESMO 2017) - P3; "...Study compared neoadjuvant SB3 or TRZ for 8 cycles concurrently with chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/cyclophosphamide)...One-year safety, immunogenicity, and survival results further support the biosimilarity established between SB3 and TRZ. Reference: 1. Pivot X et al."

Clinical • P3 data • HER2 Breast Cancer

A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Asan Medical Center | Trial completion date: Sep 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2021 ➔ Mar 2023

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Organon Canada launches Ontruzant, a biosimilar of the reference biologic Herceptin, providing patients in Canada with certain breast and gastric cancers with an additional therapeutic option at a lower cost Français (Canada Newswire) - "Organon...announced the availability and distribution of Ontruzant^®, a biosimilar of Herceptin^®, providing an additional treatment option for Canadian adults diagnosed with early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC)."

Biosimilar launch • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A randomized, double-blind, phase III study comparing SB3 (trastuzumab biosimilar) with originator trastuzumab in patients treated by neoadjuvant therapy for HER2-positive early breast cancer. (ASCO 2017) - P3; " Phase III, randomized, double blind, multicenter study compared neoadjuvant SB3 or TRZ for 8 cycles concurrently given with chemotherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide). Equivalence was demonstrated between SB3 and TRZ based on the ratio of bpCR rates. Safety, PK, and immunogenicity were similar. Complete safety and survival data will follow."

Clinical • P3 data • Serious adverse event • Biosimilar • HER2 Breast Cancer

Final survival analysis of a phase 3 study comparing SB3 (trastuzumab biosimilar) and reference trastuzumab in HER2-positive early or locally advanced breast cancer (SABCS 2021) - "Background: SB3 (trastuzumab-dttb) is a biosimilar approved globally based on its similarity with reference trastuzumab (TRZ) demonstrated by thorough comparability exercises in analytical, biological, and clinical studies. Comparable long-term efficacy results in EFS and OS were shown at 68 months of follow-up, further supporting biosimilarity of SB3 to the reference product. Currently, these follow-up results represent the longest monitoring data of patients treated with a trastuzumab biosimilar for HER2-positive early or locally advanced breast cancer."

P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2