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Byooviz
Sponsor
Device/Product name
Byooviz
Active Ingredient
Ranibizumab
Date of decision
Published
Submission type
New biosimilar medicine
ATC codes
S01LA04
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Byooviz was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
The following table summarises the key steps and dates for this comparable overseas regulator approach B (COR-B) application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 1 November 2021 |
| First round evaluation completed | 28 February 2022 |
| Sponsor provides responses on questions raised in first round evaluation | 21 April 2022 |
| Second round evaluation completed | 25 May 2022 |
| Delegate’s Overall benefit-risk assessment | 30 June 2022 |
| Sponsor’s pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 16 August 2022 |
| Completion of administrative activities and registration on ARTG | 24 August 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 152 |
*The COR-B process has a 175 working day evaluation and decision timeframe.
Date of entry onto ARTG
Black triangle scheme
No
Dose forms
Solution for injection
Strength
10 mg/mL
Other ingredients
Trehalose dihydrate, histidine hydrochloride monohydrate, histidine, polysorbate 20, water for injections
Containers
Vial
Pack sizes
One
Routes of administration
Intravitreal
Dosage
Byooviz must be administered by a qualified ophthalmologist experienced in intravitreal injections.
The recommended dose for Byooviz is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 mL. The interval between two doses injected into the same eye should be at least four weeks.
The recommended maximal dose (0.5 mg) should not be exceeded. Post-injection monitoring is recommended (see Section 4.4 special warning and precautions for use). For further information refer to the Product Information.
Pregnancy category
D
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
Byooviz (ranibizumab) was approved for the following therapeutic use:
Byooviz (ranibizumab) 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).
What is this medicine and how does it work
Byooviz (ranibizumab) is a biosimilar medicine to Lucentis (ranibizumab).
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A). It binds with high affinity to the VEGF-A isoforms (for example, VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, to the development of choroidal neovascularisation (CNV), including CNV secondary to pathologic myopia or to the macular oedema causing visual impairment in diabetes and retinal vein occlusion.
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A). It binds with high affinity to the VEGF-A isoforms (for example, VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, to the development of choroidal neovascularisation (CNV), including CNV secondary to pathologic myopia or to the macular oedema causing visual impairment in diabetes and retinal vein occlusion.
What post-market commitments will the sponsor undertake
The Byooviz European Union (EU)-risk management plan (RMP) (version 1.1, dated 17 February 2021, data lock point 4 February 2021), with Australia specific annex (version 1.2, dated 31 March 2022), included with submission PM-2021-04292-1-5, to be revised to the satisfaction of the TGA, and any subsequent revisions, will be implemented in Australia.
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of periodic safety update reports (PSURs) until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
Laboratory testing & compliance with Certified Product Details (CPD)
All batches of Byooviz (ranibizumab) supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results https://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
Certified Product Details
The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) [https://www.tga.gov.au/industry/pm-argpm-guidance-7.htm], in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- For all injectable products the Product Information must be included with the product as a package insert.