While BSR acknowledge that every new biosimilar agent will have undergone a stringent comparison against the reference medicine taking into account safety and efficacy, they note some doubts of the strength of the evidence. For example, clinical trials for each biosimilar are conducted within a small trial population for one licensed indication (usually RA).
They also note there is little evidence of the safety and effectiveness of switching to biosimilars in patients who are stable on a reference agent. Also there is a lack of knowledge of the long term safety of biosimilar drugs.
In rheumatology, the clinical trials have been of new users only, with no trial of direct substitution from an originator drug. This is significant, as biosimilar medicines are also being used as a substitute biologic for patients who are well controlled on a reference agent.
Prescription by brand name
The BSR recommend all biologics and biosimilars should be prescribed by brand name. This ensures the correct brand of medication is always prescribed.
Prescription for clinical reasons
The BSR note that clinical effectiveness and patient safety should be the overriding principles for prescribing any biologic agent. That means prescribing decisions should be made on a case by case basis, based on clinical reasons and not just to save money.
- New patients: BSR supports the inclusion of biosimilars as a biologic therapy choice for patients initiating a new biologic therapy.
Switching patients: the decision to switch patients currently receiving a reference product to a biosimilar should be on a case-by-case basis until further data are available to support safe switching. Strong safeguards are required to ensure that patients who have responded well to existing medicine who are switched for non-clinical reasons are closely monitored to ensure efficacy and safety. If patients fail to maintain the efficacy achieved on a reference product then they should have the option of reverting to this.
Substitution only with the consent of the prescribing clinician
In the event that the branded biologic or biosimilar prescribed by the clinician is unavailable, the dispensing pharmacist must contact the prescribing clinician to seek advice as to appropriate short-term alternatives.
The patient must be kept informed at all times of the discussions taking place in regard to their medicine. Patients should feel empowered to check with both the prescribing clinician and the pharmacist that the medicine dispensed is the same as that prescribed.
Decisions made in partnership with the patients
Prescribing clinicians must keep their patients fully informed about the progress of their condition and the medicines they are being prescribed.
The BSR supports the shared decision making approach, where treatment options are discussed in partnership with the patient and any decisions on potential changes to medicines, including the reasons behind these changes, are made in collaboration with, and with the informed consent of the patient.
Prescribing clinicians should make their patients aware of the process for reporting any adverse reactions to the newly prescribed biosimilar.
Registration with the BSR Biologic Registers or other appropriate UK register
There should be a robust safety monitoring strategy to protect patients and develop the long term evidence base required to provide patients and clinicians with the necessary assurances on safety and effectiveness.