PRESCRIBE BY BRAND
THE IMPORTANCE OF PRESCRIBING CLEXANE BY BRAND
Clexane offers educational resources for patients. Prescribe Clexane by brand to ensure substitution does not take place and the patient gets access to these resources across their journey. You will also support ongoing pharmacovigilance of Clexane1-2.
Watch this video to have a deeper understanding on:
This short video will include information on:
- What is a biological medicine and a biosimilar medicine
- How biologics should be prescribed
- Why it is important to prescribe enoxaparin by brand and what are the benefits for the patients
- Suggested actions
What are biological and biosimilar medicines?
A Biological medicine is a medicine that is made by or derived from a biological source, such as living cells and organisms. It is made using biotechnology processes, such as recombinant DNA technology. Biologics have large and complex structures such as proteins, hormones and growth factors. Their size and complexity, as well as the way they are produced, may result in a degree of natural variability in molecules of the same active substance, particularly indifferent batches of the medicine. This variation is maintained within strict acceptable limits.
A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine that has already been authorised by the MHRA. This biological medicine is known as the reference or originator medicine. The active substance of a biosimilar medicine is similar, but not identical, to the originator biological medicine. A biosimilar medicine is not the same as a generic medicine, which contains a simpler molecular structure that is identical to the originator medicine.
How biologics should be prescribed?
Biosimilar medicines often use the same INN (international non-proprietary name) as their reference product. In line with Medicines and Healthcare Products Regulatory Agency (MHRA) guidelines, all biological medicines, including biosimilar medicines, should be prescribed by brand name.
This is mirrored by numerous national guidelines from NICE, Scottish Medicines Consortium and NHS England. This ensures that automatics substitution of a biological product does not occur when the medicine is dispensed by the pharmacist and supports ongoing pharmacovigilance of individual products.
NHS England also states that automatic substitution is not permitted for biological medicines, including biosimilars.
The choice of whether to prescribe a biosimilar medicine or the originator biological medicine rests with the clinician in consultation with the patient.
Prescribers should use all available relevant evidence to guide decisions about the care of an individual patient.
Initial selection of the most appropriate molecule should be based on clinical considerations for the patient.
The overall value proposition oﬀered by diﬀerent products should be considered subsequently, along with other factors relevant to the use of the product and likely clinical outcomes for the patient.
Why it is important to prescribe enoxaparin by brand and what are the beneﬁts for the patients.
Enoxaparin sodium is a biological medicine and, as mentioned before, numerous national guidelines state that biological medicines should be prescribed by brand name.
In 2021, only 64% of enoxaparin prescriptions dispensed in retail speciﬁed a brand.
Prescribing by brand ensures automatic substitution of a biological product does not occur when the medicine is dispensed by the pharmacist and supports ongoing pharmacovigilance of individual products.
If pharmacists receive a prescription for a biological medicine written using the INN, the pharmacists may wish, as part of their usual clinical check, to contact the prescriber to conﬁrm which brand they intended the patient to receive.
Guidance from the Royal Pharmaceutical Society (RPS) also recommends that pharmacists should conﬁrm that the patient has received the biologic they expect at the point dispensing, and that they are aware of how to store and use the medicine.
Clexane (enoxaparin) oﬀers booklets, videos and educational resources for patients. Prescribe Clexane by brand to ensure that the patient gets access to these resources.
You might not be the ﬁrst member of your trust to prescribe enoxaparin by INN. All your team members should be made aware of biological medicines and the guidance surrounding them.
What action points can you implement to ensure your team are up to date with biological
and biosimilar medicines?
● Hold a team meeting outlining the guidance.
● Allow time to complete relevant training around biological medicines and biosimilars.
● Put posters in the dispensary with lists of biological medicines and brands available in the UK market.
What is the difference between a biological and a biosimilar medicine?
How biologics should be prescribed?
Why it is important to prescribe Clexane by brand and what are the benefits for the patients?
NATIONAL GUIDELINES RECOMMEND TO PRESCRIBE BY BRAND2-6
- Numerous national guidelines recommend that all biological medicines, including biosimilar medicines, should be prescribed by brand name2-7.
- The MHRA has confirmed that brand name prescribing for biological products is good practice7. This ensures automatic substitution of a biosimilar product does not occur when dispensed and supports ongoing pharmacovigilance of products8.
- Guidance from NHS England states that automatic substitution is not permitted for biological medicines, including biosimilars2.
WHAT IS THE CURRENT SITUATION? CHECK BELOW WHAT IS DISPENSED IN RETAIL.
- GOV.UK. Biosimilar products. Available at: https://www.gov.uk/drug-safety-update/biosimilar-products. Last accessed: April 2022.
What is a Biosimilar Medicine? May 2019. NHS England Medical Directorate.
The Association of the British Pharmaceutical Industry. Biological and biosimilar medicines in the UK. July 2014.
Scottish Medicines Consortium. Biosimilar medicines. May 2015.
NICE National Institute for Health and Care Excellence (NICE). 2014; British National Formulary – General guidance. Available at: https://bnf.nice.org.uk/guidance/guidance-on-prescribing.html. Date accessed: April 2022.
National Institute for Health and Care Excellence. KTT15: Biosimilar medicines. February 2016 (Updated February 2018).
Which medicines should be considered for brand-name prescribing in primary care? Specialist Pharmacy Service. November 2020. Available at: https://www.sps.nhs.uk/articles/example-medicines-to-prescribe-by-brand-name-in-primary-care. Last accessed: April 2022
NHS Biosimilar commissioning framework. September 2017. Medicines, Diagnostics and Personalised Medicine Policy Team, National Medical Directorate, NHS England.
Sanofi Data on File. Enoxaparin Brand Written Share Sep 2020 – Aug 2021. MAT-GB-2002244 (v2.0).
MAT-GB-2102291 (v3.0) Date of preparation: April 2022.