Dazublys (trastuzumab biosimilar) / Aurobindo - LARVOL DELTA

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2025 (European Medicines Agency) - "The committee adopted positive opinions for nine biosimilar medicines: Dazublys (trastuzumab), for the treatment of metastatic and early breast cancer."

CHMP • Breast Cancer

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of BP02 (Trastuzumab Biosimilar) Compared to EU- and US-Approved Trastuzumab in Healthy Adult Male Volunteers: A Phase 1, Randomized, Double-Blind Study. (PubMed, Oncol Ther) - "This study demonstrates the PK similarity among BP02, EU-trastuzumab, and US-trastuzumab. The safety and immunogenicity profiles observed for the three products in this study are consistent with previous reports for trastuzumab."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Pain • Respiratory Diseases

Efficacy and Safety of BP02 (Trastuzumab Biosimilar) in HER2-Positive Metastatic Breast Cancer: A Multicenter Phase III Study. (PubMed, Clin Drug Investig) - "BP02 showed an equivalent efficacy and similar safety profile to RT at the end of 24 weeks."

Journal • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Aurobindo Pharma secures marketing authorisation for Trastuzumab biosimilar in India (The Hindu Business Line) - "Aurobindo received its first marketing authorisation for the biosimilar drug trastuzumab, which is used for breast cancer treatment, in the Indian market in the current financial year...'We have promptly applied for a manufacturing license. which we expect to obtain very soon. So, the plan is to manufacture the batches and launch the product in the second half of this year [FY25] into the domestic market.'...The product, which is used in treating some types of early and metastatic breast cancers, is also filed with the European Medicines Agency by the Hyderabad-based Aurobindo, and the review procedure has already started. The filing for the US is in progress, and the company is expecting to complete the USFDA filing also in the next three months....According to Makkapati, if the procedure unfolds well with the European Medicines Agency without any glitches or without any additional data requirements, a decision may be made towards the end of Q3 or early Q4 of FY25."

Biosimilar launch • EMA filing • FDA filing • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Aurobindo Pharma subsidiary receives CDSCO nod for breast cancer treatment drug (CNBC-TV18) - "Aurobindo Pharma Ltd's wholly-owned subsidiary, CuraTeQ Biologics Private Ltd, on Wednesday,January 17, received marketing authorisation from the Central Drugs Standard Control Organization (CDSCO) for biosimilar trastuzumab. In a stock exchange filing, Aurobindo Pharma said that CureTeQ Biologics received a recommendation for grant of marketing authorisation of biosimilar trastuzumab from the Subject Experts Committee (SEC) of CDSCO, the apex drug regulator in India."

Non-US regulatory • Breast Cancer • HER2 Positive Breast Cancer • Oncology

Efficacy and safety of trastuzumab biosimilar in HER2+ve metastatic breast cancer: A multicenter phase III study (ESMO Asia 2023) - "We randomly allocated patients 1:1 stratified by ER and PR status to receive BP02 or RT (8mg/kg loading dose on day 1 of cycle 1, 6mg/kg on day 1 of cycles 2-8, each cycle lasting 3 wks) combined with docetaxel (75mg/m2 on day 1 of cycles 1-8) [induction phase]. TEAEs were seen in 58% and 60.3% patients; TEAEs leading to treatment withdrawal were reported in 2.9% and 3.2% patients, with BP02 and RT respectively. Conclusions BP02 showed equivalent efficacy and similar safety profile to RT."

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

Aurobindo Pharma Subsidiary Met Primary Endpoint In Phase 3 Clinical Trial For Trastuzumab Biosimilar Product (The Free Press) - P3 | N=914 | CTRI/2020/04/024456 | Sponsor: CuraTeQ Biologics GmbH | "Aurobindo Pharma Limited...announced that the breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by its wholly owned subsidiary company, Curateq Biologics Private Limited, has met its primary endpoint in Phase 3 clinical trial (Trial No.: CR201-18), the company on Tuesday announced through an exchange filing.....The overall response rate fell well within both the FDA risk ratio-based equivalency margin (0.80 - 1.25) and the EMA risk difference-based equivalency margin (-13, +13). The results demonstrated that BP02 met equivalence to Herceptin® in terms of clinical response and the safety profiles of the two treatment arms were shown to be comparable during the treatment phase."

P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor