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.