Approval for use

There may be variations in the process required to obtain approval for use.

ICS requirements

Integrated care systems should consider their internal requirements for biosimilar approval. Some Drug and Therapeutic Committees (DTC) may require a full formulary application, whilst others have a policy to accept biosimilars without requiring a full review. The majority of systems will require some assurance on safety and risk management prior to introduction of new biosimilars.

Actions for implementation leads

Implementation leads should check with their DTC for local requirements, making them aware of details such as:

• the choice of brand of biosimilar, including details and evidence
• the potential for ongoing switching between a range of biosimilars
• updates required to online formulary systems to reflect the choice of biosimilar by brand

To support approval, our article on The licence and supporting evidence for ranibizumab biosimilar may also be useful.

Getting It Right First Time (GIRFT) guidance may also be useful as it includes case studies outlining successful implementation programmes. Click on Adopting biosimilar ranibizumab which will take you to an NHS Futures page (login required).

Procurement and supply

When planning a go-live date for ranibizumab biosimilar, systems will need to have considered procurement and supply carefully first. Good practice includes:

Manufacturer liaison

Liaise with the manufacturer to ensure they can supply the volumes required on an ongoing basis

Pharmacy systems

Give time to ensure set-up on the pharmacy system(s) and for any financial checks to be undertaken

Stock level monitoring

Carefully monitor the stock levels of the originator product and the biosimilar, and use this to place appropriate orders for products.

Contractual frameworks

Be familiar and have in place contractual frameworks that ensure appropriate pricing and availability

Minimising dispensing errors

In order to help minimise dispensing errors, consider processes to avoid inadvertent switching between biologics if the Trust stocks both the biosimilar and originator products.

Prescribing and administration

Note the following points when prescribing biosimilars

Prescribing by brand name

Biological medicines, including biosimilars, must be prescribed by brand name.

The decision to prescribe

The decision to prescribe should be a shared one between prescriber and patient.

Patient engagement

Patient engagement is important. Giving information and creating materials for patients should be done in ways that support their sight loss with any printed materials created in accessible formats.

Patient information sheet

SPS has produced a patient information sheet that can be adapted locally. Some suggested resources have also been included for patients with visual impairment.

• Ranibizumab biosimilar Patient Information Sheet_final_March2023 v2 · PDF · 232 KB

Using paper or electronic prescribing systems

Where Trusts use paper drug charts, they should ensure the correct measures are applied.

For Trusts using electronic prescribing systems, consider medication build required to safely prescribe, dispense, and document administration. Also consider the requirements for controlling stock. The record should be built by brand name and include the ability to enter batch number and expiry dates as well as standardising to dm+d and Snomed codes. Systems should also encourage the medication administration records to document administration.

Administration

Ranibizumab biosimilars are supplied as vials.

The Byooviz, Ongavia and Ximluci SmPCs state that administration must be by a qualified ophthalmologist experienced in intravitreal injections. However, professional guidance covers administration by non-medical healthcare professionals, providing they have been fully trained in the technique of injection by an ophthalmic specialist doctor.

These requirements are the same as those for Lucentis.

Documentation

Batch numbers and expiry dates must be recorded at the point of administration using the patient’s medication record.

Monitoring

For patients

Determine if any additional local monitoring is required for patients who are switched from originator or alternative VEGF-inhibitor to ranibizumab biosimilar.

Pharmacovigilance

Report all Adverse Drug Reactions (ADRs) to MHRA (Medicines and Healthcare Products Regulatory Agency) via the Yellow Card Scheme to monitor the safety of all health products in the UK.
The biosimilar medicines and newly licensed biologics are black triangle medicines, which must be reported in this way.

Patient registries

Patient registries are important because they provide a clear method to trace patient level information related to the medication prescribed. They allow clinical teams to address concerns about pharmacovigilance, for example when patients are switched between different biosimilars of the same drug, it can be very difficult to ascertain if there are safety signals with a particular biosimilar. Registries enable us to:

• Ensure that patients prescribed biologics and biosimilars can be identified locally
• Register patients via specialist clinical areas if a national registry is available e.g. National Ophthalmology Database audit
• Report medication incidents to the local Trust via incident portal

For best value

A robust tool for reporting is needed to monitor the improved value from the biosimilar programs via platforms such as Model Health Systems dashboard, and for commissioners and finance teams if available. Blueteq or group prior approval on paper (specific to local Trust) are required to ensure transparency within the system.

Update history