dm+d

425256004

Articles

Preparing to use ranibizumab biosimilar

29 June 2022Ranibizumab biosimilar needs planning. Ensure you are familiar with the area and then develop an implementation plan working with the multidisciplinary team.

Good governance when implementing ranibizumab biosimilar

29 June 2022Governance should consider processes for approval; procurement and supply; prescribing and administration; monitoring; and pharmacovigilance.

The licence and supporting evidence for ranibizumab biosimilar

29 June 2022A licensed ranibizumab biosimilar is available from Teva: Ongavia. Learn about the licensed indications and supporting evidence.

Safety in Lactation: Subfoveal choroidal neovascularisation

21 September 2020VEGF inhibitors are used for age-related macular degeneration, administered by intravitreal injection. They are also large molecules with a high molecular weight. These factors will…
Search Articles

Refrigerated Storage

LucentisNovartis Pharmaceuticals

Novartis Pharmaceuticals
Lucentis
10 mg/mL solution for injection (vial and pre-filled syringe)

In the event of an inadvertent temperature excursion the following data may be used:

Prior to use, the unopened product may be kept at room temperature (25°C) for up to 24 hours.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

26 January 2022
London MI Service

OngaviaBioeq/Midas. UK Sales and Marketing: Teva

Bioeq/Midas. UK Sales and Marketing: Teva
Ongavia
10mg/mL solution for injection (vial)

In the event of an inadvertent temperature excursion the following data may be used:

The following temperature excursions are considered non-critical:

  • Between 8°C and 25°C for a maximum duration of 16 hours
  • Between 25°C and 30°C for a maximum duration of 4 hours
  • Between -10°C and 2°C for a maximum duration of 24 hours

Prior to use, the unopened product may be kept at room temperature (25°C) for up to 24 hours.
Contact Teva in cases where additional stability data is required. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and manufacturer’s product literature.

5 July 2022
London MI Service

Lactation Safety Information

Yes
Very limited published evidence of safety
Negligible levels anticipated in milk due to the drug’s properties
16 September 2020

New Medicines

Information

Susvimo
New formulation
Roche
Roche

Development and Regulatory status

None
Pre-registration (Filed)
Launched
Jan 22Susvimo is now available for prescribing in the US [17]
Oct 21Approved in US for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections [16].
Jul 21FDA has granted priority review [15].
Jun 21US FDA accept NDA; a decision is expected by 23/10/21 [14].
Apr 21Filed in EU. Rolling submission to FDA almost complete [13].
Feb 21EU filing now expected 2021 [12].
Feb 21Rolling submission to the US was initiated in 2020 [12].
Jul 20Roche announces results from the Archway study will be submitted to health authorities around the world, including the U.S. FDA and the EMA for consideration of regulatory approval for the treatment of nAMD [11].
Apr 20Roche pipeline lists planned filing for AMD in 2020 [7]
Oct 19EU & US filings now expected earlier in 2020 [6].
Jul 18Filings planned for 2021 or later [4].

Category

First-ever eye implant to achieve sustained delivery of ranibizumab, a vascular endothelial growth factor inhibitor.
About 1 in 100 people aged 65-75, and about 1 in 8 people aged over 85 have ARMD severe enough to cause serious visual loss. About twice as many women over the age of 75 have ARMD compared with men of the same age [1]. The wet (neovascular) form is less common but results in more serious loss of vision. the incidence of wet AMD in England is around 4.8% of those aged over 65 [2].
Wet age-related macular degeneration (AMD) - port delivery system
Implantation

Further information

Yes

Trial or other data

Feb 22Two-year results of the Archway study showed vision was maintained by Susvimo pts and continued to be non-inferior to monthly ranibizumab injections. In addition, 95% of Susvimo pts were able to go six months without needing additional treatment in the second, third and fourth refill-exchange intervals. It was generally well tolerated and had a favourable safety profile [18]
Jan 22The US Prescribing label for Susvimo has a black box warning for 3-fold higher rate of endophthalmitis with the port delivery system vs monthly ranibizumab injections. In clinical trials, 2% of patients receiving an implant experienced an episode of endophthalmitis [17].
Jul 21First patient enrolled in PIII Velodrome study [15].
Dec 20PIIIb VELODROME trial (NCT04657289; Study WR42221) is planned to start recruiting May 2021 (n=442). This global, multicentre, randomised, visual assessor-masked study is designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD). The study is expected to complete in Sep 2023 [10].
May 20Positive topline results from the randomised, multicentre, open-label PIII Archway study reported the primary endpoint was met among pts with the PDS who received refills every 6 months. The PDS was also generally well-tolerated with a favorable benefit-risk profile. The primary endpoint of the trial was the change in BCVA from a baseline at the average of Week 36 and Week 40.[8]
Jun 19Recruitment completes in PIII Archway study [6].
Apr 19PII LADDER study published in Ophthalmology 2019. pii: S0161-6420(18)33328-1 [6].
Sep 18Positive primary data from LADDER study presented at ASRS 2018 [5].
Sep 18First patient enrolled in PII/III Portal extension study (NCT03683251). 500 patients from LADDER or Archway will receive refills of 100mg/ml ranibizumab every 24 weeks; patients without the PDS will receive the PDS and subsequent refills. Primary outcome is safety [5].
Sep 18First patient enrolled in PIII Archway study (NCT03677934). 360 patients will be randomised to the ranibizumab PDS every 24 weeks or intravitreal ranibizumab every 4 weeks. Primary outcome is change in BCVA from baseline at the average of week 36 and week 40 [5].
May 18PII LADDER trial completes collection of primary outcome data [4].
Sep 17Recruitment complete in PII LADDER study [3].
Sep 15PII LADDER trial starts (NCT02510794). This is a 4-arm study in which 200 patients will be randomised to one of three ranibizumab formulations delivered via implant or Lucentis monthly intravitreal control injections. Primary outcome is time to first refill [3].

Evidence based evaluations

SusvimoDiabetic macular oedema - port delivery system

Information

Susvimo
Licence extension / variation
Roche
Roche

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

First-ever eye implant to achieve sustained delivery of ranibizumab, a vascular endothelial growth factor inhibitor.
Diabetic macular oedema (DMO) the most common cause of visual impairment in diabetes mellitus. More than 3.3 million people have been diagnosed with diabetes in England and Wales (2017), and approximately 7% of people with diabetes may have DMO [1].
Diabetic macular oedema - port delivery system
Implantation

SusvimoDiabetic retinopathy without centre-involved diabetic macular oedema - port delivery system

Information

Susvimo
Licence extension / variation
Roche
Roche

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

First-ever eye implant to achieve sustsianed delivery of ranibizumab, a vascular endothelial growth factor inhibitor
In type 1 diabetes, microaneurysms start to appear after five years in 25% of cases, affect half of cases at 10 years and nearly all patients after 20 years. Proliferative retinopathy, as defined by a formation of new vessels, appears after 10 years and affects about 40% after 20 years. In type 2 diabetes, these changes may be found at diagnosis. Over 25 years, there is a significant cumulative rate of progression to DR (83%) [1].
Diabetic retinopathy without centre-involved diabetic macular oedema - port delivery system
Intravitreal