AryoTrust (trastuzumab biosimilar) / Inno Bio, AryoGen Pharmed - LARVOL DELTA

Safety evaluation of the trastuzumab biosimilar in Iranian women with HER2-positive breast cancer undergoing adjuvant chemotherapy: a post-marketing surveillance. (PubMed, Expert Opin Drug Saf) - P=N/A | "The results demonstrate that this trastuzumab biosimilar is a generally well-tolerated and safe treatment for HER2-positive BC. www.clinicaltrials.gov identifier is NCT06021379."

Journal • P4 data • Brain Cancer • Breast Cancer • CNS Tumor • HER2 Breast Cancer • HER2 Positive Breast Cancer • Meningioma • Musculoskeletal Pain • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor • HER-2

A randomized, double-blind, phase III, non-inferiority clinical trial comparing the efficacy and safety of TA4415V (a proposed Trastuzumab biosimilar) and Herceptin (Trastuzumab reference product) in HER2-positive early-stage breast Cancer patients. (PubMed, BMC Pharmacol Toxicol) - "Non-inferiority for efficacy was demonstrated between TA4415V and Herceptin based on the ratio of pCR rates in HER2-positive early breast cancer patients. In addition, ORR and BCS, as secondary endpoints, were not significantly different. Safety profile and immunogenicity were also comparable between the two groups."

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

AryoTrust® (Trastuzumab) Safety Study (clinicaltrials.gov) - P=N/A | N=597 | Completed | Sponsor: AryoGen Pharmed Co.

New trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Availability and affordability of anticancer medicines in Iran based on WHO/HAI standard survey methods. (PubMed, Support Care Cancer) - "Unaffordability of cancer medicines can lead to treatment abandonment and increase inequality in access to healthcare services. Therefore, this requires immediate attention of policy makers to be planned in order to ensure to reducing the costs of medicines for patients and increasing patient access to anticancer medicines."

Journal • Breast Cancer • Cardiovascular • Oncology • Solid Tumor

A Randomized, Double-blind, Parallel Pharmacokinetic Study Comparing the Trastuzumab Biosimilar Candidate, AryoTrust®, and Reference Trastuzumab in Healthy Subjects. (PubMed, Expert Opin Investig Drugs) - "AryoTrust® was well tolerated, had a similar safety profile to reference trastuzumab, and its pharmacokinetic bioequivalence was confirmed. Trial Registration The trial is registered at Indian Trials Registry (CTRI/2019/03/018218)."

Clinical • Journal • PK/PD data • Breast Cancer • Oncology • Solid Tumor

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer (clinicaltrials.gov) - P3; N=108; Completed; Sponsor: AryoGen Pharmed Co.; Recruiting ➔ Completed

Clinical • Head-to-Head • Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust®) Versus Herceptin® in Breast Cancer (clinicaltrials.gov) - P3; N=108; Recruiting; Sponsor: AryoGen Pharmed Co.; Trial completion date: Oct 2018 ➔ Mar 2019; Trial primary completion date: Oct 2018 ➔ Mar 2019

Clinical • Head-to-Head • Trial completion date • Trial primary completion date