AIFA classifies Dazublys, a trastuzumab biosimilar for breast and gastric cancer

The Italian Medicines Agency (AIFA) has classified the trastuzumab biosimilar medicinal product “Dazublys” in class C(nn), the section reserved for drugs not yet evaluated for reimbursement purposes. The decision is contained in determination no. 1340/2026 of October 1, 2026, signed by president Roberto Giovanni Nisticò, and published in the Official Gazette of the Italian Republic, General Series no. 236 of October 10, 2026 (code 26A05311).

Classification and Regulatory Framework

The measure is adopted pursuant to Article 12, paragraph 5, of Law no. 189 of November 8, 2012, which regulates the placement in class C(nn) of newly authorized medicinal products awaiting the application for classification in a reimbursement bracket. The opinion on the classification regime for supply purposes was expressed by the Scientific and Economic Commission (CSE) of AIFA during the session of September 7-11, 2026.

The marketing authorization holder is Curateq Biologics (Malta) Limited. The drug was authorized via European procedure EMA/VR/0000304280, ATC code L01FD01, with the decision published in the Official Journal of the European Union on July 17, 2026.

• Authorized packaging: EU/1/25/1949/002, A.I.C. 052340027
• Form: 420 mg, powder for concentrate for solution for infusion, intravenous use, glass vial, 1 vial
• Reimbursement class: C(nn)
• Supply regime: restrictive medical prescription, to be renewed each time, sellable to the public upon prescription from hospital centers or specialists — oncologist (RNRL)
• Entry into force: the day following publication in the Official Gazette

Indications: HER2-positive breast and gastric carcinoma

According to the annex to the determination, “Dazublys” is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC), as monotherapy or in combination with paclitaxel, docetaxel, or an aromatase inhibitor, and in HER2-positive early breast cancer (EBC), following surgery, chemotherapy (neoadjuvant or adjuvant), and radiotherapy, if applicable.

The medicinal product is also indicated, in combination with capecitabine or 5-fluorouracil and cisplatin, for adult patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not previously received antitumor treatment for metastatic disease. The determination of HER2 expression using an accurate and validated test is mandatory before starting therapy.

Administration, Safety, and Monitoring

The loading dose should be administered by intravenous infusion lasting ninety minutes; subsequent doses may be reduced to thirty minutes if the first is well tolerated. Patients must remain under observation for at least six hours after the start of the first infusion and for two hours after subsequent ones.

The product is subject to additional monitoring, and the holder must ensure compliance with the pharmacovigilance requirements set out in the Risk Management Plan (RMP) and the periodic safety update reports (PSUR) according to the EURD list. The determination also refers to the patent and labeling obligations borne by the biosimilar holder.

Impact for patients and prescribers

The classification as C(nn) means that the drug is available but not reimbursed by the National Health Service pending a different classification: prescription remains reserved for oncologists and specialists in a hospital setting. For patients with HER2-positive tumors, the range of trastuzumab biosimilars is expanded, while subsequent classification and reimbursement measures will be published on AIFA’s “Trovanorme” portal.

Source: Official Gazette of the Italian Republic, General Series no. 236 of October 10, 2026 — AIFA Determination no. 1340/2026 of October 1, 2026, “Classification, pursuant to Article 12, paragraph 5, of Law 8 November 2012, no. 189, of the medicinal product for human use, based on trastuzumab, ‘Dazublys’” (26A05311).