Ogivri (trastuzumab-dkst) / Biocon, Sandoz - LARVOL DELTA

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

Real-world evidence on Trastuzumab biosimilars in Taiwan: evaluating utilization, efficacy, and safety in HER2-positive breast cancer (SG-BCC 2025) - " This study included 114 HER2-positive breast cancer patients treated with trastuzumab biosimilars (OGIVRI®, trastuzumab-dkst) between February 2020 and December 2022. Our real-world findings indicate that trastuzumab biosimilars are a safe and cost-effective alternative to reference trastuzumab for the treatment of HER2-positive breast cancer. Trastuzumab biosimilars showed effective results in the neoadjuvant setting, and dual blockade with biosimilars provided slightly improved disease control in the metastatic setting. Further follow-up is required to assess the long-term efficacy of trastuzumab biosimilars in the adjuvant setting."

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

An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies. (PubMed, BioDrugs) - "The Python-based tool offers a high-throughput and a reliable platform for glycosimilarity assessment, outperforming traditional analysis. Minor variations in glycosylation patterns were observed among the biosimilars, suggesting a modest glycosimilarity variation (GI range between 80 and 100%). However, the limited number of innovator batches analyzed constrained the establishment of definitive tolerance limits. Future studies should focus on analyzing larger datasets to improve accuracy and define precise tolerance limits, enhancing the tool's reliability and its potential to accelerate biosimilar development."

Journal

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

Tucatinib, Trastuzumab and Capecitabine with brain and/or spinal radiotherapy (XRT) in patients with HER2+ metastatic breast cancer and leptomeningeal disease: A multi-centre phase II, single arm feasibility study ("CLIMB LMD"; NCT06016387) (SABCS 2024) - P2 | "Tucatinib, trastuzumab (Ogivri; MYL-1401O) and capecitabine will be administered as per the HER2CLIMB protocol; however, the addition of capecitabine may be delayed and commence during Cycle 2, at the discretion of the treating physician to allow for adequate recovery from XRT. To-date (July 3, 2024), 4 patients have enrolled. The expected accrual period is 18 to 24 months."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-World Assessment of biosimilar Trastuzumab MYL-1401O vs. reference Trastuzumab in HER2-Positive Breast Cancer: Utilization, Efficacy, and Safety in Asian patients (SABCS 2024) - "The study focused on HER2-positive EBC patients who received neoadjuvant chemotherapy with RTZ or MYL-1401O ± pertuzumab (n = 140) and untreated stage IV MBC patients who received first-line palliative treatment with RTZ or MYL-1401O ± pertuzumab (n = 150). This real-world study demonstrates that MYL-1401O is as effective and safe as RTZ in Asian patients with HER2-positive EBC or MBC, supporting its clinical utility in these populations."

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

Biocon Q2FY25 Revenue at Rs 3,623 Cr, EBITDA at Rs 718 Cr (Biocon Press Release) - "Biocon Biologics has positioned itself as a strategic player among customers, payors, and patients in North America...Its Oncology franchise, comprising Ogivri (Trastuzumab) and Fulphila (Pegfilgrastim), is witnessing robust demand with a marked YoY increase in market share. The market share for Ogivri increased to 18% from 11%, while Fulphila rose to 21% from 15% (YoY)."

Commercial • Breast Cancer • Chemotherapy-Induced Neutropenia • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Immunomodulation profile of the biosimilar trastuzumab MYL-1401O in a bioequivalence phase I study. (PubMed, Sci Rep) - "This approach may thus be included in a proof-of-concept study. CRA may be used as a predictive assay for the evaluation of clinical monoclonals."

Clinical • Immunomodulating • Journal • P1 data • P1 data • Immunology • CD8 • CSF2 • IFNG • IL10 • IL1B • IL2 • IL6 • TNFA

Real-World Study of Adjuvant Biosimilar Trastuzumab-dkst for HER2-Positive Breast Cancer Treatment in a Brazilian Population. (PubMed, Oncol Ther) - P=N/A | "Our study reinforces the existing pivotal data, underscoring the real-world efficacy and safety of biosimilar trastuzumab-dkst in the adjuvant treatment for early HER2-positive breast cancer. The preliminary long-term effectiveness and safety data we present further validate trastuzumab-dkst's role as a cost-saving alternative in oncological care. These findings have important implications for improving patient access to crucial treatments and for the more efficient use of healthcare resources."

Journal • Real-world • Real-world evidence • Breast Cancer • 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

Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes. (PubMed, JMIR Cancer) - P, P=N/A | "Treatment of patients with HER2-positive BC with the trastuzumab biosimilar Ogivri resulted in equivalent symptoms, adverse events, and well-being as found for patients treated with Herceptin as determined by ePRO data. Hence, integration of an ePRO system into research and clinical practice can provide reliable information when investigating the real-world tolerability and outcomes of similar therapeutic compounds."

Journal • Observational data • Patient reported outcomes • Real-world • Real-world evidence • Anorexia • Breast Cancer • CNS Disorders • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Sleep Disorder • Solid Tumor • HER-2

Biocon Biologics Partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab (PRNewswire) - "Biocon Biologics Ltd...announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million) and biosimilar Bevacizumab (market value of AUD$45 million) in Australia. Under the agreement, Sandoz will distribute the Biocon Biologics' brands, OGIVRI (bTrastuzumab) and ABEVMY (bBevacizumab), and facilitate the sustained access of these medications that were previously distributed by another pharmaceutical company to patients in Australia....The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024."

Licensing / partnership • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Glioblastoma • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries (Biocon Press Release) - "Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd...announced the successful completion of the transition of the acquired biosimilars business in ~120 countries across Advanced and Emerging Markets, a year ahead of schedule....All Viatris’ biosimilar brands, including Ogivri® & Hertraz® (bTrastuzumab), Abevmy® (bBevacizumab), Fulphila® (bPegfilgrastim)...and Kirsty® (bAspart), will now be marketed by Biocon Biologics teams, ensuring business continuity for patients, prescribers, partners, and healthcare systems."

M&A • Chemotherapy-Induced Neutropenia • CNS Tumor • Gastrointestinal Cancer • Oncology • Solid Tumor

SABCS Posters Evaluate Real-World Outcomes Associated With Ogivri (Center for Biosimilars) - "Two Taiwanese posters from the San Antonio Breast Cancer Symposium...The first study aimed to assess the utilization, efficacy, and safety of trastuzumab biosimilars, specifically Ogivri, in the treatment of patients with HER2-positive breast cancer...The study reported positive clinical outcomes, with a 40.90% pathological complete response rate in the neoadjuvant group, a 57.14% objective response rate, and a 90.47% clinical benefit rate in the metastatic group...The prospective observational study included 52 women with HER2-positive breast cancer treated with Ogivri in various settings...Results indicated that, among the 92 symptoms available, 84 were recorded, with an average of more than 2 symptoms per day, totaling 10,532 individual patient entries....Overall, symptoms associated with Ogivri were reported with a similar incidence and distribution compared with Herceptin, with slightly lower scores. "

Observational data • Real-world • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

HER2-directed biosimilar Ogivri in the treatment of breast cancer: real world reporting of symptoms and wellbeing using electronic patient reported outcome (ePRO) (SABCS 2023) - P=N/A | "Methodology: In this prospective observational study, patients with HER2-positive BC were treated with OgivriTM alone +/- Pertuzumab, +/- Chemotherapy and hormone therapy in neo-adjuvant, adjuvant and non-curative settings...Of note, when treatments were compared restricted to the trastuzumab antihormones and trastuzumab- paclitaxel therapies, this reported trend seamed weaker... No difference was reported for symptoms, adverse events, and well-being with respect to the Trastuzumab biosimilar OgivriTM in comparison with HerceptinTM. The integration of ePRO into research and clinical practice provides reliable information when investigating real world tolerability and outcomes of similar therapeutic compounds."

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

Real-world evidence of Trastuzumab biosimilars in HER2-positive breast cancer: Evaluating utilization, efficacy, and safety in Taiwan (SABCS 2023) - "Methods A total of 113 HER2-positive breast cancer patients were enrolled between February 2020 and December 2022 and treated with trastuzumab biosimilars (OGIVRI®, trastuzumab-dkst). Biosimilar trastuzumab demonstrated efficacy in the neoadjuvant setting, while dual blockade with biosimilars resulted in better disease control in the metastatic setting. Further follow-up is necessary to evaluate the efficacy of trastuzumab biosimilars in the adjuvant setting."

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

A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab. (PubMed, Curr Oncol) - "After controlling for clinically relevant variables, there was no significant difference in the odds of achieving tpCR in patients treated with TRZ versus MYL-1401O (OR 1.1, 95% CI 0.5-2.4, p = 0.850). tpCR rates were similar for patients treated with MYL-1401O compared to trastuzumab in our real world study of HER2+ neoadjuvant EBC and comparable to pivotal phase 3 trials."

Journal • Real-world evidence • Retrospective data • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

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

Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer. (PubMed, Breast Cancer Res Treat) - P3 | "This is the first phase 3 trial of a trastuzumab biosimilar to report long-term survival data similar to originator trastuzumab in patients with MBC. The comparable long-term OS between the trastuzumab-dkst and originator trastuzumab groups further supports the similarity of trastuzumab-dkst with originator trastuzumab and establishes trastuzumab-dkst as a safe and effective treatment option for patients with HER2-positive MBC. ClinicalTrials.gov NCT02472964; 6/16/2015."

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

Evaluation of biosimilar trastuzumab MYL-1401O in HER2-positive breast cancer. (PubMed, Am J Manag Care) - "These data suggest that biosimilar trastuzumab MYL-1401O has similar effectiveness and cardiac safety to RTZ in patients with HER2-positive EBC or MBC."

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

Adherence to standardized and structured electronic symptom reporting (ePRO) via mobile app in HER2-positive breast cancer treated with HER2 biosimilar trastuzumab (ESMO 2023) - P=N/A | "Methods In this 6 week observational study, patients were treated with trastuzumab (Ogivri®) +/- Pertuzumab, +/- Chemotherapy +/- anti-hormones. Conclusions The majority of patients continued the ePRO app use after end of study participation. Only 1 drop out (from 53 pats) was noted in this propsective observational study."

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

LB1802: Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer (clinicaltrials.gov) - P=N/A | N=170 | Active, not recruiting | Sponsor: Libbs Farmacêutica LTDA | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2024 ➔ Jul 2028 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Enrollment closed • Real-world • Real-world evidence • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

FDA-Approved Drugs: Biologic License Application (BLA): 761074 (FDA) - Supplemental BLA for Ogivri approved on 3rd October 2023

sBLA • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer