BYOOVIZ

What it is

Byooviz contains ranibizumab, a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology. Byooviz is a biosimilar medicine approved by the TGA on 16 August 2022. The medicine is supplied as a vial containing 2.3 mg of ranibizumab in 0.23 mL solution for intravitreal injection.

Approved indications Byooviz is indicated in adults for:

— the treatment of neovascular (wet) age-related macular degeneration (AMD) — the treatment of visual impairment due to diabetic macular oedema (DME) — treatment of proliferative diabetic retinopathy (PDR) — the treatment of visual impairment due to choroidal neovascularisation (CNV) — the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM) — the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO)

Dosing overview

The recommended dose for Byooviz in adults is 0.5 mg given as a single intravitreal injection, corresponding to an injection volume of 0.05 mL. The interval between two doses injected into the same eye should be at least four weeks. Treatment is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity. In patients with wet AMD, DME, PDR, and RVO, initially three or more consecutive monthly injections may be needed. Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters. If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME.

Key safety warnings

Byooviz must be administered by a qualified ophthalmologist experienced in intravitreal injections. Use of more than one injection from a vial can lead to product contamination and subsequent ocular infection. The injection procedure should be carried out under aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum or equivalent. Sterile paracentesis equipment should be available as a precautionary measure. Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.

Regulatory history

Byooviz (ranibizumab 10 mg/mL solution for injection vial) was first listed on the ARTG on 24 August 2022. Byooviz was approved by the TGA on 16 August 2022 as a biosimilar medicine. The TGA evaluation, supported by a COR-B process using EMA reports, found Byooviz to be biosimilar, demonstrating comparable physicochemical, biological, immunological, efficacy, and safety profiles to the reference medicine Lucentis.