ABEVMY

What it is

ABEVMY is a biosimilar medicine containing bevacizumab (rch) injection. The evidence for comparability supports the use of ABEVMY for the listed indications. ABEVMY is available in 100 mg and 400 mg single dose vials containing 4 mL and 16 mL, respectively, of bevacizumab (25 mg/mL). ABEVMY is a clear to slightly opalescent, colourless to pale brown, sterile solution for intravenous (IV) infusion. Bevacizumab is a recombinant humanised monoclonal antibody that selectively binds to and neutralises the biologic activity of human vascular endothelial growth factor (VEGF). Bevacizumab inhibits the binding of VEGF to its receptors on the surface of endothelial cells, and neutralising the biologic activity of VEGF reduces the vascularisation of tumours, thereby inhibiting tumour growth.

Approved indications

— Metastatic colorectal cancer, in combination with fluoropyrimidine-based chemotherapy. — Locally recurrent or metastatic breast cancer, in combination with paclitaxel, for first-line treatment in patients in whom an anthracycline-based therapy is contraindicated. — Advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel, for first-line treatment of unresectable disease. — Advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a. — Grade IV glioma as a single agent, for treatment after relapse or disease progression after standard therapy, including chemotherapy. — Advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages IIIB, IIIC and IV), in combination with carboplatin and paclitaxel, for first-line treatment. — Recurrent platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, in patients who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors. — Recurrent platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin, in patients who have received no more than two prior chemotherapy regimens and have not received any prior anti-angiogenic therapy. — Persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin.

Dosing overview

For metastatic colorectal cancer, first-line treatment: 5 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg of body weight given once every 3 weeks. Second-line treatment: 10 mg/kg of body weight given every 2 weeks or 15 mg/kg of body weight given once every 3 weeks. For locally recurrent or metastatic breast cancer: 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks. For advanced, metastatic or recurrent non-squamous NSCLC: 15 mg/kg of body weight given once every 3 weeks in combination with carboplatin and paclitaxel. For advanced and/or metastatic renal cell cancer: 10 mg/kg given once every 2 weeks. For Grade IV glioma: 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks. For cervical cancer: 15 mg/kg of body weight given once every 3 weeks. Dose reduction of ABEVMY for adverse reactions is not recommended; if indicated, ABEVMY should either be discontinued or temporarily suspended.

Key safety warnings

Patients may be at increased risk for gastrointestinal (GI) perforation and gallbladder perforation when treated with bevacizumab, and bevacizumab should be permanently discontinued in patients who develop GI perforation. GI perforations have been reported in clinical trials with an incidence of less than 1% in patients with metastatic breast cancer or NSCLC, up to 2% in patients with metastatic colorectal cancer or ovarian cancer (first-line treatment), and up to 2.7% in patients with metastatic colorectal cancer (including GI fistula and abscess), with fatal outcome reported in approximately a third of serious cases. An increased incidence of hypertension was observed in patients treated with bevacizumab, and clinical safety data suggest that the incidence is likely to be dose-dependent. Pre-existing hypertension should be adequately controlled before starting bevacizumab treatment, and monitoring of blood pressure is recommended during bevacizumab therapy. Bevacizumab should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy. Bevacizumab may adversely affect the wound healing process; bevacizumab therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed, and in patients who experience wound healing complications during bevacizumab therapy, bevacizumab should be withheld until the wound is fully healed. An increased incidence of arterial thromboembolic events has been observed in patients treated with bevacizumab across indications, with the overall incidence ranging up to 5.9% in the bevacizumab-containing arms compared with up to 1.7% in the chemotherapy control arms. Bevacizumab should be permanently discontinued in patients who develop arterial thromboembolic events. Patients treated with bevacizumab have an increased risk of haemorrhage, especially tumour-associated haemorrhage, and bevacizumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding during bevacizumab therapy. Patients with NSCLC treated with bevacizumab may be at risk for serious, and in some cases fatal, pulmonary haemorrhage/haemoptysis, and patients with recent pulmonary haemorrhage/haemoptysis (greater than ½ teaspoon red blood) should not be treated with bevacizumab.

Contraindications

ABEVMY is contraindicated in patients with known hypersensitivity to any components of the product, Chinese hamster ovary cell products or other recombinant human or humanised antibodies.

PBS listing

ABEVMY is registered on the ARTG in two strengths: 100 mg/4 mL concentrate injection for solution vial (ARTG 334816) and 400 mg/16 mL concentrate injection for solution vial (ARTG 334814), both first listed on 2021-09-06. The PBAC recommended a Section 100 Authority Required (Streamlined) listing for bevacizumab in combination with platinum-based chemotherapy plus paclitaxel for the treatment of persistent, recurrent or metastatic cervical cancer in March 2016. In May 2019, the PBAC recommended a Section 100 (Efficient Funding of Chemotherapy) Authority Required listing for relapsed or refractory glioblastoma. PBS listing information including current ex-manufacturer price is not provided in the available source documents.

Regulatory history

ABEVMY was approved by the TGA on 10 May 2021 as a new biosimilar medicine, with the TGA's evaluation finding no outstanding quality concerns and no meaningful nonclinical differences compared to the reference product Avastin. In March 2016, the PBAC recommended a Section 100 Authority Required (Streamlined) listing for bevacizumab in combination with platinum-based chemotherapy plus paclitaxel for persistent, recurrent or metastatic cervical cancer on the basis of cost-effectiveness. In May 2019, the PBAC recommended a Section 100 Authority Required listing for relapsed or refractory glioblastoma, noting high unmet clinical need and improvements in response rates and progression-free survival.