Simulara, Solentis and Zivra (ranibizumab)
Simulara, Solentis and Zivra are approved to treat the following conditions in adults:
neovascular (wet) age-related macular degeneration
visual impairment due to diabetic macular oedema
proliferative diabetic retinopathy
visual impairment due to choroidal neovascularisation
visual impairment due to choroidal neovascularisation secondary to pathologic myopia
visual impairment due to macular oedema secondary to retinal vein occlusion.
The active ingredient in Simulara, Solentis and Zivra is ranibizumab (rbe).
Solentis
Zivra
Simulara, Solentis and Zivra are biosimilar medicines to Lucentis, a medicine that is already approved and registered in Australia. A biosimilar medicine is highly similar to an approved medicine in terms of quality, effectiveness and safety.
Simulara, Solentis and Zivra are used in adults to treat:
- neovascular (wet) age-related macular degeneration (wet AMD), a chronic eye disease that causes loss of central vision
- visual impairment due to diabetic macular oedema (DME), fluid buildup and swelling in the central part of the retina (the macula) in people with diabetes
- proliferative diabetic retinopathy, an advanced stage of diabetic eye disease involving growth of new blood vessels on the retina
- visual impairment due to choroidal neovascularisation (CNV), a condition where new blood vessels grow underneath the retina
- visual impairment due to CNV secondary to pathologic myopia (PM), where new blood vessels grow beneath the retina in people with severe short-sightedness
- visual impairment due to macular oedema secondary to retinal vein occlusion (RVO), where fluid builds up in the macula due to blockage of the retinal vein.
Simulara, Solentis and Zivra are given by an ophthalmologist (eye doctor) as an injection into the eye under a local anaesthetic.
Ranibizumab (rbe) is the active ingredient in Simulara, Solentis, Zivra, and Lucentis (the reference medicine). It works by blocking the action of a protein in the eye called vascular endothelial growth factor A (VEGF-A).
High levels of VEGF-A can cause abnormal growth of blood vessels in the eye. These blood vessels can leak fluid or blood and cause swelling, which can damage vision.
To support registration in Australia, the sponsor company submitted evidence from laboratory and clinical studies comparing Simulara, Solentis and Zivra with the reference medicine, Lucentis.
Overall, the evidence showed that Simulara, Solentis and Zivra are highly similar to Lucentis (the reference medicine), with no clinically meaningful differences in quality, effectiveness or safety.
Key findings from the laboratory and clinical studies
- Laboratory studies showed that Simulara, Solentis and Zivra have highly similar physical, chemical and biological properties to Lucentis (the reference medicine).
- A Phase 1 (early-stage) clinical study confirmed the well-established finding that only low levels of ranibizumab enter the bloodstream after it is injected into the eye. Similar levels of ranibizumab were observed for Simulara, Solentis, Zivra and Lucentis (the reference medicine), with no clinically meaningful differences between the products.
- A Phase 3 (main) clinical study in 600 patients with neovascular AMD showed that Simulara, Solentis, and Zivra produced similar improvements in the condition to Lucentis (the reference medicine). Neovascular AMD is considered a suitable condition to detect potential differences between similar products.
- Safety findings were similar for Simulara, Solentis, Zivra and Lucentis (the reference medicine), and no new safety concerns were identified.
- The most commonly reported side effects with Simulara, Solentis and Zivra include eye discomfort, feeling of having something in the eye or the eye not feeling normal, dry eye, spots in front of the eye (floaters), teary, pain/irritation at injection site, and allergic reactions (rash, itching, redness of the skin).
For comprehensive information on the potential side effects and risks of Simulara, Solentis and Zivra, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Simulara, Solentis, and Zivra and the medicines can be registered in Australia.
More detailed information on why the TGA approved Simulara, Solentis, and Zivra will be published in the upcoming Australian Public Assessment Report (AusPAR).
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
Australian CMIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
Australian PIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
- SIMULARA ranibizumab (rbe) 1.65mg/0.165 mL solution for injection pre-filled syringe (492733)
- SIMULARA ranibizumab (rbe) 2.3mg/0.23mL solution for injection vial (504365)
- SOLENTIS ranibizumab (rbe) 1.65mg/0.165 mL solution for injection pre-filled syringe (504065)
- SOLENTIS ranibizumab (rbe) 2.3mg/0.23mL solution for injection vial (504307)
- ZIVRA ranibizumab (rbe) 1.65mg/0.165 mL solution for injection pre-filled syringe (504045)
- ZIVRA ranibizumab (rbe) 2.3mg/0.23mL solution for injection vial (504306)
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.
Simulara, Solentis and Zivra must be administered by a qualified ophthalmologist experienced in intravitreal injections (injections into the vitreous humour, a jelly-like substance in the eye).